T–Z

Template

Select a Quantitative response assay template.

Note: If you define more than one Quantitative response assay template, all but one templates need the Valid for replicate restriction.


Data type	Multiplicity	Usage	Default value
Node	1...1	required	none

/Basic bioassay protocol/Templates/Assay templates/Assay template/

Template

Select a Combination of assay results template for this configuration.


Data type	Multiplicity	Usage	Default value
Node	1...1	required	none

/Basic bioassay protocol/Templates/Combination calculation templates/Configuration/

Template key

Select a template to require referenced documents be generated by this template.


Data type	Multiplicity	Usage	Default value
xs:token	0...1	optional	none

/Basic bioassay protocol/Reportable values/Document reference/

/Combination of independent assay results/Setup/Potency data/Column: Document reference/

/Equivalence margin development (Quantitative response assays)/Data table/Column: Document reference/

/Quantitative response assay/Setup/Observation data/Column: Document reference/

Template selection strategy

Select a Template selection strategy from the drop-down list.

Once you have generated assay replicates, these options allow you to generate additional replicates or new versions of existing replicates.

Existing replicates: If you increase the number of replicates in all or some of your Test or Control samples and generate again, additional replicates are created.
Existing elements: If you increase the number of replicates in all or part of your Test or Control samples and generate again, new versions of existing replicates are created.

Note: The Template selection strategy options only apply to protocols in Assay element mode.


Data type	Multiplicity	Usage	Default value
xs:token	1...1	required	none

/Basic bioassay protocol/Templates/Assay templates/

Templates

This section allows you to specify the templates you need to generate assay replicates and combination calculations.


Data type	Multiplicity	Usage	Default value
Node	1...1	required	none

/Basic bioassay protocol/

Term

Enter a term to define the value of the related property. If you do not enter a term, only the Property key itself is used as a filter, not its value. If you define multiple terms, the system combines them using the logical OR, which means that only one of the terms has to match.

Tip: Use the asterisk (*) as a wildcard to cover several assay element Names with a single Term. Enter 'St*', for example, to aggregate Standard samples that are named 'Standard' or 'Std'.

Example: To aggregate Test samples, use a single term and enter 'Test' as its value. To aggregate both Test and Control samples, add a second term and enter 'Control' as its value.


Data type	Multiplicity	Usage	Default value
xs:string	1...unbounded	optional	none

/Combination of independent assay results/Setup/Potency data/Column: Section/Property filter/

Term

Enter a term to define the value of the related property. If you do not enter a term, only the Property key itself is used as a filter, not its value. If you define multiple terms, the system combines them using the logical OR, which means that only one of the terms has to match.

Tip: Use the asterisk (*) as a wildcard to cover several Property key values with a single term.


Data type	Multiplicity	Usage	Default value
xs:string	0...unbounded	optional	none

/Basic bioassay protocol/Templates/Combination calculation templates/Configuration/Template/Config/Document property filter/

/Basic bioassay protocol/Comment/Linked document/Config/Document property filter/

/Combination of independent assay results/Setup/Potency data/Column: Document reference/Document property filter/

/Equivalence margin development (Quantitative response assays)/Data table/Column: Document reference/Document property filter/

/Quantitative response assay/Setup/Observation data/Column: Document reference/Document property filter/

Term

Currently, no information available.


Data type	Multiplicity	Usage	Default value
xs:token	1...unbounded	required	none

/Equivalence margin development (Quantitative response assays)/Data table/Column: Assay element/Property filter/

Test: Coefficient of variation (%)

Add one or several tests for the coefficient of variation (CV) of potencies to your assay. This test checks the CV of relative/absolute potencies entered in the data table.

To pass the test, the observed value must be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

Note: The CV is calculated individually for each combination group.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Combination of independent assay results/Analysis/Suitability tests/choice/

Test: Combined log potency confidence interval width (L-term)

Add one or several tests for the confidence interval of the combined logarithmized potency to your assay.

Usually, this test checks the length of the combined logarithmic relative potency/absolute potency confidence interval. With slope ratio models, this test checks the relative potency/potency confidence interval instead of the logarithmic relative potency/potency confidence interval.

To pass the test, the observed value must be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

Note: The logarithmic potency confidence interval is also known as L-term, for example, in USP <111>.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Combination of independent assay results/Analysis/Suitability tests/choice/

Test: Combined potency confidence interval

Add one or several tests for the confidence interval of the combined potency to your assay.

To pass the test, the observed value must be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Combination of independent assay results/Analysis/Suitability tests/choice/

Test: Combined potency confidence interval (%)

Add one or several tests for the percentual confidence interval of the combined potency to your assay.

This test allows you to define upper and lower margins for the percentual potency confidence interval, that is, the confidence interval relative to the absolute or relative potency value, expressed as a percental value.

To pass the test, the observed value must be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Combination of independent assay results/Analysis/Suitability tests/choice/

Test: Combined potency confidence interval range (%)

Add one or several tests for the percentual confidence interval range of the combined potency to your assay.

To pass the test, the observed value must be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Combination of independent assay results/Analysis/Suitability tests/choice/

Test: Combined potency value

Add one or several tests for the combined potency value to your assay.

To pass the test, the observed value must be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Combination of independent assay results/Analysis/Suitability tests/choice/

Test exception handling

Select how the test system behaves when tests return 'not calculated' (NC) results.

Note: Tests return 'not calculated' (NC) results if they cannot run due to exceptions such as division by zero, ANOVA error term is zero, or nonlinear optimizer cannot find a solution (fit) for a model that is required for the test.

The following options are available from the drop-down list:

strict: Handles NC test results as failed tests.
informal: Reports NC test results, but otherwise ignores them.


Data type	Multiplicity	Usage	Default value
xs:token	1...1	required	none

/Quantitative response assay/Analysis/Suitability tests/

Test: Geometric coefficient of variation (%)

Add one or several tests for the percentual geometric coefficient of variation (CV) to your assay.

To pass the test, the observed value must be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

The geometric CV is calculated as follows:

GCV (%) = 100 \cdot (GSD - 1)

Where GSD is:

GSD = b^{\sqrt{\frac{1}{n - 1} \cdot \sum_{i=1}^{n} (\log_{b} (x_{i}) - \log_{b} (GM))^{2}}}

And GM is:

GM = {(\prod_{i = 1}^{n} x_{i})}^{1 ⁄ n}

Where: b is the chosen base from analysis settings.

Note: The geometric CV is calculated individually for each combination group.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Combination of independent assay results/Analysis/Suitability tests/choice/

Test: Homogeneity

Add one or several Chi-square tests of homogeneity to your assay.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Combination of independent assay results/Analysis/Suitability tests/choice/

Test: Log potency range (L-value)

Add one or several tests for the range of the logarithmized potency to your assay. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the difference of the logarithmized upper confidence limit minus the logarithmized lower confidence limit of the parameter has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

4-parameter logistic, 5-parameter logistic

Test, Control


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/

Test: Log potency range (L-value)

Add one or several tests for the range of the logarithmized potency to your assay.

To pass the test, the observed value must be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Combination of independent assay results/Analysis/Suitability tests/choice/

Test: Maximal number of outliers

Add one or several tests for the maximal number of outliers to your assay. The test counts technical outliers, statistical outliers, and missing values. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the number of technical and statistical outliers and missing values has to be less than or equal to the Upper margin set in the test definition.

Tip: Use the scope and extent settings to select the assay elements for which the maximal number of outliers is to be calculated.

Linear parallel-line, 4-parameter logistic, 5-parameter logistic, 3-parameter logistic with fixed lower asymptote, 3-parameter logistic with fixed upper asymptote, Slope ratio

Standard only: Runs the test for the Standard sample.
Test samples only: Runs the test for every Test sample.
Control samples only: Runs the test for every Control sample.
Control lines only: Runs the test for every Control line.
All assay elements: Runs the test for every assay element.

Assay element: Runs the test on the data of individual assay elements. Example: If you set the scope of the test to 'Test samples only', the test is evaluated for each individual Test sample.
Assay (without simultaneous regression): Runs the test on the data of individual Test-vs-Standard and Control-vs-Standard comparisons. Example: If you set the scope of the test to 'Test samples only', the test is evaluated for each individual Test-vs-Standard comparison. The observations of each sample pair are regarded as a dataset for which the number of outliers is determined.
Assay (simultaneous regression): Runs the test on the data of the whole assay. Example: If you set the scope of the test to 'Test samples only', the test is evaluated for the whole assay. The observations of all samples are regarded as one single dataset for which the number of outliers is determined.
Sequence step: Runs the test on the data of individual sequence steps. To pass the test, the number of outliers of each sequence step has to be less than or equal to the Upper margin. Example: If you set the scope of the test to 'Test samples only', the test is evaluated for each individual sequence step of the Test samples.

Note: If you set the Extent of the test to 'Assay', the test is either evaluated for each Standard-vs-Test sample comparison or the whole assay in the case of simultaneous regression. Therefore, also setting the Assay element type scope to 'Standard only' is not supported.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/

Test: Maximal sequence step CV (%)

Add one or several tests for the maximal percentual coefficient of variation (CV) of sequence steps to your assay.

The percentual CV is calculated as follows:

C V = | \frac{Standard Deviation}{Mean} | \cdot 100

Note: Technical and statistical outliers are excluded from the calculation of the CV. The test returns an 'NC' (not calculated) if one or more sequence steps have only one observation.

To pass the test, all sequence step CVs have to be less than or equal to the Upper margin set in the test definition.

Linear parallel-line, 4-parameter logistic, 5-parameter logistic, 3-parameter logistic with fixed lower asymptote, 3-parameter logistic with fixed upper asymptote, Slope ratio

Standard only: Runs the test for the Standard sample.
Test samples only: Runs the test for every Test sample.
Control samples only: Runs the test for every Control sample.
Control lines only: Runs the test for every Control line.
All assay elements: Runs the test for every assay element.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/

Test: Mean coefficient of variation (%)

Add one or several tests for the mean percentual coefficient of variation (CV) to your assay.

This test allows you to define upper and lower margins for the arithmetic mean of the percentual CV values. The percentual CV values are derived from the absolute or relative potency confidence intervals which are used as input values of the combination calculation.

To pass the test, the observed value must be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Combination of independent assay results/Analysis/Suitability tests/choice/

Test: Minimal R²

Add one or several tests for the minimal R² to your assay. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the R² of the restricted regression fit has to be greater than or equal to the Lower margin set in the test definition. If a method to calculate the R² value is specified, this also affects the method used to evaluate this test.

All

Standard, Test, Control

Assay element: Runs the test on the data of individual assay elements.
Assay: Runs the test on the data of the whole assay.

Note: If you set the Extent of the test to 'Assay', the test is either evaluated for each Standard-vs-Test sample comparison or the whole assay in the case of simultaneous regression. Therefore, also setting the Assay element type scope to 'Standard only' is not supported.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/

Test name

Enter a name for the test. Test names are used to reference tests in Conditional evaluations. To make the test results available for data aggregation, the name should not exceed 400 characters. Longer names are shortened automatically and may become unreadable.

Note: We recommend using only ASCII characters for the name. Non-ASCII characters are converted to ASCII, which increases the length of the name.


Data type	Multiplicity	Usage	Default value
xs:token	0...1	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/F-test (hypothesis test)/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Equivalence test: Parameter estimate/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Equivalence test: Difference of parameter estimates/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Equivalence test: Ratio of parameter estimates/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Equivalence test: Scaled parameter range/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Point estimate test: Parameter estimate/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Point estimate test: Difference of parameter estimates/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Point estimate test: Ratio of parameter estimates/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Normalized difference of asymptotes/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Sum of squares regression/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Sum of squares non-parallelism/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Sum of squares non-linearity/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Ratio sum of squares non-linearity / sum of squares regression/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Potency value/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Potency confidence interval/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Log potency range (L-value)/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Potency of intermediate dilution/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Potency confidence interval (%)/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Potency range (%)/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Weight (W)/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Maximal number of outliers/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Maximal sequence step CV (%)/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Minimal R²/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Relative LOF error (%)/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Response value range/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Root mean square error (RMSE)/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/F-test (hypothesis test)/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Equivalence test: Parameter estimate/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Equivalence test: Difference of parameter estimates/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Equivalence test: Ratio of parameter estimates/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Equivalence test: Scaled parameter range/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Point estimate test: Parameter estimate/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Point estimate test: Difference of parameter estimates/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Point estimate test: Ratio of parameter estimates/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Normalized difference of asymptotes/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Sum of squares regression/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Sum of squares non-parallelism/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Sum of squares non-linearity/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Ratio sum of squares non-linearity / sum of squares regression/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Potency value/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Potency confidence interval/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Log potency range (L-value)/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Potency of intermediate dilution/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Potency confidence interval (%)/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Potency range (%)/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Weight (W)/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Maximal number of outliers/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Maximal sequence step CV (%)/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Minimal R²/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Relative LOF error (%)/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Response value range/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Root mean square error (RMSE)/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/F-test (hypothesis test)/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Equivalence test: Parameter estimate/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Equivalence test: Difference of parameter estimates/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Equivalence test: Ratio of parameter estimates/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Equivalence test: Scaled parameter range/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Point estimate test: Parameter estimate/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Point estimate test: Difference of parameter estimates/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Point estimate test: Ratio of parameter estimates/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Normalized difference of asymptotes/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Sum of squares regression/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Sum of squares non-parallelism/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Sum of squares non-linearity/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Ratio sum of squares non-linearity / sum of squares regression/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Potency value/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Potency confidence interval/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Log potency range (L-value)/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Potency of intermediate dilution/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Potency confidence interval (%)/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Potency range (%)/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Weight (W)/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Maximal number of outliers/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Maximal sequence step CV (%)/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Minimal R²/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Relative LOF error (%)/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Response value range/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Root mean square error (RMSE)/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/F-test (hypothesis test)/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Equivalence test: Parameter estimate/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Equivalence test: Difference of parameter estimates/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Equivalence test: Ratio of parameter estimates/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Equivalence test: Scaled parameter range/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Point estimate test: Parameter estimate/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Point estimate test: Difference of parameter estimates/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Point estimate test: Ratio of parameter estimates/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Normalized difference of asymptotes/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Sum of squares regression/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Sum of squares non-parallelism/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Sum of squares non-linearity/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Ratio sum of squares non-linearity / sum of squares regression/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Potency value/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Potency confidence interval/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Log potency range (L-value)/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Potency of intermediate dilution/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Potency confidence interval (%)/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Potency range (%)/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Weight (W)/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Maximal number of outliers/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Maximal sequence step CV (%)/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Minimal R²/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Relative LOF error (%)/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Response value range/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Root mean square error (RMSE)/

Test: Number of invalid assays

Add one or several tests for the number of invalid assays to your assay.

This test allows you to define upper and lower margins for the number of invalid assays, that is, assays with the status 'Failed'.

To pass the test, the observed value must be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Combination of independent assay results/Analysis/Suitability tests/choice/

Test: Number of valid assays

Add one or several tests for the number of valid assays to your assay.

This test allows you to define upper and lower margins for the number of valid assays, that is, assays with the status 'Passed' or 'Passed (info available)'.

To pass the test, the observed value must be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Combination of independent assay results/Analysis/Suitability tests/choice/

Test: Normalized difference of asymptotes

Add one or several tests for the normalized difference of asymptotes to your assay. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the following ratio has to be greater than the Lower and less than the Upper margin, respectively: (selected asymptote (Test/Control) - selected asymptote (Standard)) / (upper asymptote (Standard) - lower asymptote (Standard))

After defining the test you have to select the parameter:

Normalized A upper asymptote
Normalized D lower asymptote

Test samples only: Runs the test for every Test sample.
Control samples only: Runs the test for every Control sample.
All assay elements: Runs the test for every assay element except Standard sample and Control lines.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/

Test: Normalized difference of lower asymptotes

Use this test for the following models:

4-parameter logistic fit
4-parameter logistic fit with included blanks
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
Empty	0...1	optional	none

/Equivalence margin development (Quantitative response assays)/Margin development/Tests: Normalized difference of asymptotes/

Test: Normalized difference of upper asymptotes

Use this test for the following models:

4-parameter logistic fit
4-parameter logistic fit with included blanks
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
Empty	0...1	optional	none

/Equivalence margin development (Quantitative response assays)/Margin development/Tests: Normalized difference of asymptotes/

Test on user variable

Add one or several tests for a user variable to your assay.

Note: If you enter the Key of a User variable in the test definition, but no Value, the test only checks whether the Key exists. To have the test check the Value of the User variable, you must also enter the Value in the test definition.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Document suitability tests/

/Test system definition (Quantitative response assay)/Suitability tests/Document suitability tests/

Test: Potency confidence interval

Add one or several tests for the potency confidence interval to your assay. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the lower confidence limit of the relative potency has to be greater than or equal to the Lower margin set in the test definition, and the upper confidence limit of the potency has to be less than or equal to the Upper margin.

Linear parallel-line, 4-parameter logistic, 5-parameter logistic, 3-parameter logistic with fixed lower asymptote, 3-parameter logistic with fixed upper asymptote, Slope ratio

Test, Control


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/

Test: Potency confidence interval (%)

Add one or several tests for the percentual potency confidence interval to your assay. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the lower confidence limit of the percentual relative potency has to be greater than or equal to the Lower margin set in the test definition, and the upper confidence limit of the percentual potency has to be less than or equal to the Upper margin.

Linear parallel-line, 4-parameter logistic, 5-parameter logistic, 3-parameter logistic with fixed lower asymptote, 3-parameter logistic with fixed upper asymptote, Slope ratio

Test, Control


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/

Test: Potency of intermediate dilution

Add one or several tests for the intermediate dilution potency to your assay. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the potency of the specified intermediate dilution has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

Linear parallel-line, 4-parameter logistic, 5-parameter logistic, 3-parameter logistic with fixed lower asymptote, 3-parameter logistic with fixed upper asymptote, Slope ratio

Standard, Test, Control


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/

Test: Potency range (%)

Add one or several tests for the relative-potency range to your assay. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the percentual relative-potency range has to be less than or equal to the Upper margin set in the test definition.

Linear parallel-line, 4-parameter logistic, 5-parameter logistic, 3-parameter logistic with fixed lower asymptote, 3-parameter logistic with fixed upper asymptote, Slope ratio

Test, Control


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/

Test: Potency spread (%)

Add one or several tests for the precentual spread of potencies to your assay.

This test allows you to define an Upper margin for the percentual spread of relative/absolute potencies used in the combination calculation.

To pass the test, the observed value must be less than or equal to the Upper margin.

The potency spread (PS) is calculated as follows:

PS = \frac{Max (Potencies) - Min (Potencies)}{Max (Potencies)} \cdot 100

Note: The potency spread is evaluated individually for each combination group.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Combination of independent assay results/Analysis/Suitability tests/choice/

Test: Potency value

Add one or several tests for the potency value to your assay. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the potency value has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

Linear parallel-line, 4-parameter logistic, 5-parameter logistic, 3-parameter logistic with fixed lower asymptote, 3-parameter logistic with fixed upper asymptote, Slope ratio

Test, Control


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/

Test: Pure error

Use this test for the following models:

Linear parallel-line model
Slope ratio model
4-parameter logistic fit
4-parameter logistic fit with included blanks
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
Empty	0...1	optional	none

/Equivalence margin development (Quantitative response assays)/Margin development/Additional tests/

Test: Ratio sum of squares non-linearity / sum of squares regression

Use this test for the following models:

Linear parallel-line model
Slope ratio model
4-parameter logistic fit
4-parameter logistic fit with included blanks
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
Empty	0...1	optional	none

/Equivalence margin development (Quantitative response assays)/Margin development/Additional tests/

Test: Ratio sum of squares non-linearity / sum of squares regression

Add one or several tests for the ratio of sum of squares non-linearity (sum-of-squares lack of fit) to sum of squares regression to your assay. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the ratio must be greater than or equal to the Lower margin and less than or equal to the Upper margin.

Note: We do not recommend this test if you have statistical or technical outliers. The number of observations should be equal across all assays, that is, assays for which you use this test and historical assays used in margin development.

Linear parallel-line, 4-parameter logistic, 5-parameter logistic, 3-parameter logistic with fixed lower asymptote, 3-parameter logistic with fixed upper asymptote, Slope ratio

The Standard sample is always included in the calculation.
'Test samples only' or 'Control samples only' without simultaneous regression: The test is computed for each Test-vs-Standard or Control-vs-Standard comparison.
'All assay elements' without simultaneous regression: The test is computed for each Test-vs-Standard and for each Control-vs-Standard comparison.

Note: With simultaneous regression (formerly called multiplex assay), all samples are regarded as one single dataset and are tested together (not as individual samples or pairwise comparisons).


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/

Test reference

Select the test whose results are to determine whether this test is to be executed.

Note: We recommend to set the Severity level of the referenced test to 'Information'.


Data type	Multiplicity	Usage	Default value
xs:string	1...1	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/F-test (hypothesis test)/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Equivalence test: Parameter estimate/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Equivalence test: Difference of parameter estimates/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Equivalence test: Ratio of parameter estimates/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Equivalence test: Scaled parameter range/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Point estimate test: Parameter estimate/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Point estimate test: Difference of parameter estimates/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Point estimate test: Ratio of parameter estimates/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Normalized difference of asymptotes/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Sum of squares regression/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Sum of squares non-parallelism/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Sum of squares non-linearity/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Ratio sum of squares non-linearity / sum of squares regression/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Potency value/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Potency confidence interval/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Log potency range (L-value)/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Potency of intermediate dilution/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Potency confidence interval (%)/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Potency range (%)/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Weight (W)/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Maximal number of outliers/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Maximal sequence step CV (%)/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Minimal R²/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Relative LOF error (%)/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Response value range/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/Test: Root mean square error (RMSE)/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/F-test (hypothesis test)/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Equivalence test: Parameter estimate/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Equivalence test: Difference of parameter estimates/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Equivalence test: Ratio of parameter estimates/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Equivalence test: Scaled parameter range/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Point estimate test: Parameter estimate/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Point estimate test: Difference of parameter estimates/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Point estimate test: Ratio of parameter estimates/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Normalized difference of asymptotes/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Sum of squares regression/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Sum of squares non-parallelism/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Sum of squares non-linearity/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Ratio sum of squares non-linearity / sum of squares regression/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Potency value/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Potency confidence interval/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Log potency range (L-value)/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Potency of intermediate dilution/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Potency confidence interval (%)/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Potency range (%)/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Weight (W)/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Maximal number of outliers/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Maximal sequence step CV (%)/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Minimal R²/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Relative LOF error (%)/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Response value range/Conditional evaluation/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/Test: Root mean square error (RMSE)/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/F-test (hypothesis test)/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Equivalence test: Parameter estimate/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Equivalence test: Difference of parameter estimates/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Equivalence test: Ratio of parameter estimates/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Equivalence test: Scaled parameter range/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Point estimate test: Parameter estimate/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Point estimate test: Difference of parameter estimates/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Point estimate test: Ratio of parameter estimates/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Normalized difference of asymptotes/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Sum of squares regression/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Sum of squares non-parallelism/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Sum of squares non-linearity/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Ratio sum of squares non-linearity / sum of squares regression/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Potency value/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Potency confidence interval/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Log potency range (L-value)/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Potency of intermediate dilution/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Potency confidence interval (%)/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Potency range (%)/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Weight (W)/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Maximal number of outliers/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Maximal sequence step CV (%)/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Minimal R²/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Relative LOF error (%)/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Response value range/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/Test: Root mean square error (RMSE)/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/F-test (hypothesis test)/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Equivalence test: Parameter estimate/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Equivalence test: Difference of parameter estimates/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Equivalence test: Ratio of parameter estimates/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Equivalence test: Scaled parameter range/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Point estimate test: Parameter estimate/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Point estimate test: Difference of parameter estimates/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Point estimate test: Ratio of parameter estimates/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Normalized difference of asymptotes/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Sum of squares regression/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Sum of squares non-parallelism/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Sum of squares non-linearity/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Ratio sum of squares non-linearity / sum of squares regression/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Potency value/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Potency confidence interval/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Log potency range (L-value)/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Potency of intermediate dilution/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Potency confidence interval (%)/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Potency range (%)/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Weight (W)/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Maximal number of outliers/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Maximal sequence step CV (%)/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Minimal R²/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Relative LOF error (%)/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Response value range/Conditional evaluation/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/Test: Root mean square error (RMSE)/Conditional evaluation/

Test: Relative LOF error (%)

Add one or several tests for the relative lack-of-fit error to your assay. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the relative lack-of-fit error has to be less than or equal to the Upper margin set in the test definition.

The relative lack-of-fit error is calculated as follows:

R = \frac{\sqrt{\frac{S}{N}}}{A - D} \cdot 100

Where S is the sum-of-squares lack of fit from the ANOVA table, N is the total number of observations, a is the upper asymptote, and d is the lower asymptote.

4-parameter logistic, 3-parameter logistic with fixed lower asymptote, 3-parameter logistic with fixed upper asymptote

Test, Control


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/

Test: Residual error

Use this test for the following models:

Linear parallel-line model
Slope ratio model
4-parameter logistic fit
4-parameter logistic fit with included blanks
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
Empty	0...1	optional	none

/Equivalence margin development (Quantitative response assays)/Margin development/Additional tests/

Test: Response value range

Add one or several tests for the response value range to your assay. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the minimal response value of the assay element has to be greater than or equal to the Lower margin set in the test definition, and the maximal response value of the assay element has to be less than or equal to the Upper margin. The original values are always used, even if a Response transformation has been set. Technical and statistical outliers are excluded.

Note: The test always uses untransformed response values. Response adjustments and Response transformations are not taken into account.

Linear parallel-line, 4-parameter logistic, 5-parameter logistic, 3-parameter logistic with fixed lower asymptote, 3-parameter logistic with fixed upper asymptote, Slope ratio

Standard only: Runs the test for the Standard sample.
Test samples only: Runs the test for every Test sample.
Control samples only: Runs the test for every Control sample.
Control lines only: Runs the test for every Control line.
All assay elements: Runs the test for every assay element.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/

Test: Root mean square error (RMSE)

Add one or several tests for the root mean square error to your assay. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the square root of mean square error of the unrestricted regression fit has to be less than or equal to the Upper margin set in the test definition.

All

Standard only: Runs the test for the Standard sample.
Test samples only: Runs the test for every Test sample.
Control samples only: Runs the test for every Control sample.
All assay elements: Runs the test for every assay element except Control lines.

Assay element: Runs the test on the data of individual assay elements. Example: If you set the scope of the test to 'Test samples only', the test is evaluated for each individual Test sample.
Assay (without simultaneous regression): Runs the test on the data of individual Test-vs-Standard and Control-vs-Standard comparisons. Example: If you set the scope of the test to 'Test samples only', the test is evaluated for each individual Test-vs-Standard comparison.
Assay (simultaneous regression): Runs the test on the data of the whole assay. Example: If you set the scope of the test to 'Test samples only', the test is evaluated for the whole assay.

Note: If you set the Extent of the test to 'Assay', the test is either evaluated for each Standard-vs-Test sample comparison or the whole assay in the case of simultaneous regression. Therefore, also setting the Assay element type scope to 'Standard only' is not supported.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/

Test sample

This section allows you to provide information on a Test sample, also referred to as preparation sample or unknown. The potency of Test samples is calculated in comparison to the Standard sample.

Tip: The Group element allows you to mark Test samples for inclusion in a combination calculation. You need a Combination of assay results document to do the actual combination calculation.

To provide information on the substance: Add the elements you need, such as Substance name or Substance reference, from the Creatable elements pane.

Expand the node to add or view information.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	required	none

/Basic bioassay protocol/choice/Mode: Assay element/

/Quantitative response assay/Setup/Assay elements/

Test: Signature status

Add one or several tests for the signature state to your assay.

Tip: Use the Meaning and Number of signatures elements to specify the signature and the number of signatures required.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Combination of independent assay results/Analysis/Suitability tests/choice/

Test strategies

This section allows you to define the test strategies you want to evaluate in verification and visualization.

Expand the node to add or view information.


Data type	Multiplicity	Usage	Default value
Node	1...1	required	none

/Equivalence margin development (Quantitative response assays)/

Test strategy verification

Select the 'yes' option from the drop-down list to use the development and verification assays to evaluate all test strategies you define.


Data type	Multiplicity	Usage	Default value
xs:token	1...1	required	none

/Equivalence margin development (Quantitative response assays)/Settings/

Test strategy visualization

Select the 'yes' option from the drop-down list to generate and visualize the parameter configurations that pass the defined test strategies. The parameter configurations are processed for each test strategy separately.

Note: Additional tests are not considered in the visualization.


Data type	Multiplicity	Usage	Default value
xs:token	1...1	required	none

/Equivalence margin development (Quantitative response assays)/Settings/

Test: Sum of squares non-linearity

Add or delete tests for specific assay elements.

The following options are available:

Test: Sum of squares non-linearity (all): Combines the terms for non-linearity of the Standard sample and the Test/ Control sample.
Test: Sum of squares non-linearity (Standard only): Only uses the terms for non-linearity of the Standard sample.
Test: Sum of squares non-linearity (Test/Control): Only uses the terms for non-linearity of the Test/ Control sample.

Expand the node to add or view information.


Data type	Multiplicity	Usage	Default value
Node	0...1	optional	none

/Equivalence margin development (Quantitative response assays)/Margin development/Additional tests/

Test: Sum of squares non-linearity

Add one or several tests for the sum of squares non-linearity (also known as sum of squares lack of fit) to your assay. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the sum of squares non-linearity (from the ANOVA table) has to be less than or equal to the Upper margin set in the test definition.

Note: We do not recommend this test if you have statistical or technical outliers. The number of observations should be equal across all assays, that is, assays for which you use this test and historical assays used in margin development.

Linear parallel-line, 4-parameter logistic, 5-parameter logistic, 3-parameter logistic with fixed lower asymptote, 3-parameter logistic with fixed upper asymptote, Slope ratio

The Standard sample is always included in the calculation.
'Standard only' without simultaneous regression (each Test or Control sample is compared separately to the Standard): No test is computed.
'Test samples only' or 'Control samples only' without simultaneous regression: The test is computed for each Test-vs-Standard or Control-vs-Standard comparison.
'All assay elements' without simultaneous regression: The test is computed for each Test-vs-Standard and for each Control-vs-Standard comparison.

Note: With simultaneous regression (formerly called multiplex assay), all samples are regarded as one single dataset and are tested together (not as individual samples or pairwise comparisons).

Assay element: Runs the test on the data of individual assay elements.
Assay: Runs the test on the data of the whole assay.

Note: If you set the Extent of the test to 'Assay', the test is either evaluated for each Standard-vs-Test sample comparison or the whole assay in the case of simultaneous regression. Therefore, also setting the Assay element type scope to 'Standard only' is not supported.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/

Test: Sum of squares non-linearity (all)

Use this test for the following models:

Linear parallel-line model
Slope ratio model
4-parameter logistic fit
4-parameter logistic fit with included blanks
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
Empty	0...1	optional	none

/Equivalence margin development (Quantitative response assays)/Margin development/Additional tests/Test: Sum of squares non-linearity/

Test: Sum of squares non-linearity (Standard only)

Use this test for the following models:

Linear parallel-line model
Slope ratio model
4-parameter logistic fit
4-parameter logistic fit with included blanks
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
Empty	0...1	optional	none

/Equivalence margin development (Quantitative response assays)/Margin development/Additional tests/Test: Sum of squares non-linearity/

Test: Sum of squares non-linearity (Test/Control)

Use this test for the following models:

Linear parallel-line model
Slope ratio model
4-parameter logistic fit
4-parameter logistic fit with included blanks
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
Empty	0...1	optional	none

/Equivalence margin development (Quantitative response assays)/Margin development/Additional tests/Test: Sum of squares non-linearity/

Test: Sum of squares non-parallelism

Use this test for the following models:

Linear parallel-line model
Slope ratio model
4-parameter logistic fit
4-parameter logistic fit with included blanks
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
Empty	0...1	optional	none

/Equivalence margin development (Quantitative response assays)/Margin development/Additional tests/

Test: Sum of squares non-parallelism

Add one or several tests for the sum of squares non-parallelism to your assay. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the sum of squares non-parallelism (from the ANOVA table) has to be less than or equal to the Upper margin set in the test definition.

Note: We do not recommend this test if you have statistical or technical outliers. The number of observations should be equal across all assays, that is, assays for which you use this test and historical assays used in margin development.

Linear parallel-line, 4-parameter logistic, 5-parameter logistic, 3-parameter logistic with fixed lower asymptote, 3-parameter logistic with fixed upper asymptote, Slope ratio

The Standard sample is always included in the calculation.
'Test samples only' or 'Control samples only' without simultaneous regression: The test is computed for each Test-vs-Standard or Control-vs-Standard comparison.
'All assay elements' without simultaneous regression: The test is computed for each Test-vs-Standard and for each Control-vs-Standard comparison.

Note: With simultaneous regression (formerly called multiplex assay), all samples are regarded as one single dataset and are tested together (not as individual samples or pairwise comparisons).


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/

Test: Sum of squares regression

Use this test for the following models:

Linear parallel-line model
Slope ratio model
4-parameter logistic fit
4-parameter logistic fit with included blanks
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
Empty	0...1	optional	none

/Equivalence margin development (Quantitative response assays)/Margin development/Additional tests/

Test: Sum of squares regression

Add one or several tests for the sum of squares regression to your assay. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the sum of squares regression (from the ANOVA table) has to be less than or equal to the Upper margin set in the test definition.

Note: We do not recommend this test if you have statistical or technical outliers. The number of observations should be equal across all assays, that is, assays for which you use this test and historical assays used in margin development.

Linear parallel-line, 4-parameter logistic, 5-parameter logistic, 3-parameter logistic with fixed lower asymptote, 3-parameter logistic with fixed upper asymptote, Slope ratio

The Standard sample is always included in the calculation.
'Test samples only' or 'Control samples only' without simultaneous regression: The test is computed for each Test-vs-Standard or Control-vs-Standard comparison.
'All assay elements' without simultaneous regression: The test is computed for each Test-vs-Standard and for each Control-vs-Standard comparison.

Note: With simultaneous regression (formerly called multiplex assay), all samples are regarded as one single dataset and are tested together (not as individual samples or pairwise comparisons).


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/

Test: Sum of weights

Add one or several tests for the sum of weights to your assay. This test allows you to define upper and lower margins for the sum of weights.

To pass the test, the observed value must be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

Note: In this context, weight refers to the homogeneous weights, not the corrected weights that are used for heterogeneous weighting.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Combination of independent assay results/Analysis/Suitability tests/choice/

Test system definition (Quantitative response assay)

Defines a collection of Suitability tests and corresponding margins for Quantitative response assays.

You can reference this Test system definition document from Quantitative response assays. When you calculate an assay that references this document, the test(s) specified in this document are applied to the assay.

1. Expand the node to add or view information. The second level of the document structure displays the Name and Date of the document.

2. Double-click the Identification element in the Creatable elements pane to add it to the document.

Tip: To delete an element from the document, right-click the element in the document structure and select the Delete element option from the pop-up menu.

3. Double-click the Comment element in the Creatable elements pane to add a Comment section to the document.


Data type	Multiplicity	Usage	Default value
Node	1...1		none

Top level

Test system reference

Select a Test system definition document.


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/

Test: Weight (W)

Add one or several tests for the weight to your assay. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the potency weight has to be greater than or equal to the Lower margin set in the test definition.

Note: The weight is defined in the European Pharmacopoeia 6.0, Chapter 5.3, Equation 6.2.1.-1.

Linear parallel-line, 4-parameter logistic, 5-parameter logistic, 3-parameter logistic with fixed lower asymptote, 3-parameter logistic with fixed upper asymptote, Slope ratio

Test, Control


Data type	Multiplicity	Usage	Default value
Node	0...unbounded	optional	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/

Tests: Normalized difference of asymptotes

Select the tests for which you want to develop margins. In this section, you can select tests for the normalized difference of assymptotes.


Data type	Multiplicity	Usage	Default value
Node	0...1	optional	none

/Equivalence margin development (Quantitative response assays)/Margin development/

Tests: Normalized difference of asymptotes

Select the tests you want to use to define your test strategy. In this section, you can select tests for the normalized difference of assymptotes.


Data type	Multiplicity	Usage	Default value
Node	0...1	optional	none

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/

Text

Enter your comment.

Tip: You can enter multiline text. You can also add additional Text elements.


Data type	Multiplicity	Usage	Default value
xs:string	0...unbounded	optional	none

/Basic bioassay protocol/Comment/

/Combination of independent assay results/Comment/

/Equivalence margin development (Quantitative response assays)/Comment/

/Quantitative response assay/Comment/

/Test system definition (Quantitative response assay)/Comment/

Tolerance level

Specifies what proportion of data is to lie within developed margins. Select 95%, for example, to exclude the outer 5% data values from the calculation. A common value is 95%.

A higher tolerance level results in a greater equivalence range (distance between equivalence margins).

Note: Use of tolerance levels below 100% in margin development inevitably causes some development assays to fail tests based on calculated margins. Select the 100% tolerance level if all development assays should pass the developed margins.


Data type	Multiplicity	Usage	Default value
xs:double	1...1	required	none

/Equivalence margin development (Quantitative response assays)/Settings/

Transformation

Transform your response values using Logarithmic, Square, or Square root response transformation.

Example: Use this feature to mitigate problems caused by the heteroscedasticity of your response data.

Expand the node to add or view information.


Data type	Multiplicity	Usage	Default value
Node	0...1	optional	none

/Quantitative response assay/Analysis/Response data processing/choice/

Transformed dose maximum

Enter a decimal number to be used as greatest value of the x-axis in simulation plots.


Data type	Multiplicity	Usage	Default value
xs:double	0...1	optional	none

/Equivalence margin development (Quantitative response assays)/Visualization/Transformed dose range/

Transformed dose minimum

Enter a decimal number to be used as least value of the x-axis in simulation plots.


Data type	Multiplicity	Usage	Default value
xs:double	0...1	optional	none

/Equivalence margin development (Quantitative response assays)/Visualization/Transformed dose range/

Transformed dose range

Defines the least and greatest value of the x-axis used for simulation plots. These values only apply if no assays are referenced. Otherwise, the values of the referenced assays are used.

Note: If the model selected for visualization is 'Slope ratio', the values are considered absolute dose values. For all other models, the values are considered log dose values.


Data type	Multiplicity	Usage	Default value
Node	0...1	optional	none

/Equivalence margin development (Quantitative response assays)/Visualization/

Type

Select the type of F-test you want to use from the drop-down list.

Please consult the help page on the F-test (hypothesis test) for additional information.


Data type	Multiplicity	Usage	Default value
xs:token	1...1	required	none

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/choice/F-test (hypothesis test)/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/choice/F-test (hypothesis test)/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/choice/F-test (hypothesis test)/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/choice/F-test (hypothesis test)/

Unit

Enter the unit of the response values.


Data type	Multiplicity	Usage	Default value
xs:token	0...1	optional	none

/Quantitative response assay/Setup/Observation data/Column: Response value/

Update mode

Select how you want to update document references and the data provided by these documents.

Tip: You can update data based on a list of referenced documents (update data) or a property filter (update all). To update data based on a property filter, you have to add a Document property filter or a Section property filter to the Document reference section.

The following four Update modes are available:


Mode	Trigger	Scope
Auto all	Updates automatically when you open or close the document.	Searches the entire database for data matching the property filter. Updates all matching data and the list of referenced documents.
Auto data	Updates automatically when you open or close the document.	Updates data from currently referenced documents.
Manual all	Updates when you manually execute the update command in the References editor.	Searches the entire database for data matching the property filter. Updates all matching data and the list of referenced documents.
Manual data	Updates when you manually execute the update command in the References editor.	Updates data from currently referenced documents.

Note: Only documents for which the requesting user has read permission are checked for updates.


Data type	Multiplicity	Usage	Default value
xs:token	0...1	optional	none

/Basic bioassay protocol/Reportable values/Document reference/

/Combination of independent assay results/Setup/Potency data/Column: Document reference/

/Equivalence margin development (Quantitative response assays)/Data table/Column: Document reference/

/Quantitative response assay/Setup/Observation data/Column: Document reference/

Update mode

Select how you want to update data provided by the referenced document.

The following options are available from the drop-down list:

Auto: Have data updated automatically.
Manual: Update data manually from the References dialog.


Data type	Multiplicity	Usage	Default value
xs:token	1...1	required	none

/Basic bioassay protocol/Documentation/choice/Substance reference/Config/

/Basic bioassay protocol/choice/Mode: Assay element/Standard sample/choice/Substance reference/Config/

/Basic bioassay protocol/choice/Mode: Assay element/Test sample/choice/Substance reference/Config/

/Basic bioassay protocol/choice/Mode: Assay element/Control sample/choice/Substance reference/Config/

/Basic bioassay protocol/choice/Mode: Assay element/Control line/choice/Substance reference/Config/

/Combination of independent assay results/Documentation/choice/Substance reference/Config/

/Combination of independent assay results/Documentation/Groups/Group/choice/Substance reference/Config/

/Equivalence margin development (Quantitative response assays)/Comment/Linked Document/Config/

/Quantitative response assay/Documentation/choice/Substance reference/Config/

/Quantitative response assay/Documentation/Reagent/choice/Reagent reference/Config/

/Quantitative response assay/Setup/Assay elements/Standard sample/choice/Substance reference/Config/

/Quantitative response assay/Setup/Assay elements/Test sample/choice/Substance reference/Config/

/Quantitative response assay/Setup/Assay elements/Control sample/choice/Substance reference/Config/

/Quantitative response assay/Setup/Assay elements/Control line/choice/Substance reference/Config/


Data type	Multiplicity	Usage	Default value
xs:token	0...1	required	none

/Equivalence margin development (Quantitative response assays)/Comment/Linked Document/Config/

Upper asymptote (A) (nonlinear models)

This parameter is used for the following models:

4-parameter logistic fit
4-parameter logistic fit with included blanks
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
Node	0...1	optional	none

/Equivalence margin development (Quantitative response assays)/Visualization/Simulation space/

Upper asymptote (A) (nonlinear models)

Use this test for the following models:

4-parameter logistic fit
4-parameter logistic fit with included blanks
5-parameter logistic fit


Data type	Multiplicity	Usage	Default value
Empty	0...1	optional	none

/Equivalence margin development (Quantitative response assays)/Margin development/Equivalence tests: Parameter estimate/

Upper margin

Enter the Upper margin of the test as decimal number. To pass the test, the observed value must be less than or equal to the Upper margin.

Tip: Set up an Equivalence margin document in PLA if you have historical data to determine the margins for your tests.

Please consult the help page of the test for additional information.


Data type	Multiplicity	Usage	Default value
xs:double	1...1	required	none