Q–S

Find reference information on document elements of the Biological Assay Package, letters Q to S.

Quality weight

Select the Quality weight you want to use for configuration optimization.

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

  • Coefficient of determination
  • F-ratio regression
  • Slope

Coefficient of determination

The configuration optimizer selects ranges with higher R² value.

Important: The Coefficient of determination is the default Quality weight option of PLA. If you consider using one of the other options, you must confirm suitability of your method for you assay.

F-ratio regression

The configuration optimizer selects ranges with higher F-ratio regression.

Note: With the F-ratio regression option, you must select the Residual-error ANOVA option for ANOVA model. If you use the Pure Error ANOVA option, the calculation is aborted with an error message. If F-ratio regression cannot be calculated, the value is set to '0'.

Slope

The configuration optimizer selects ranges with greater absolute value of the Slope of the restricted regression model.

Note: The Quality weight is used during range selection. It only affects the calculation if the 'Optimization on' option is set in the current Data selection scheme.

The behavior of Quality weight also depends on which option you select for the Configuration optimizer allocation range.

  • If you select Best range: The configuration optimizer first finds all configurations with minimal severity index. Of these, the configuration with optimal Quality weight is determined.
  • If you select Maximum range: The configuration optimizer first finds all configurations with minimal severity index. It then selects the configurations with maximal number of dose steps. Of these, the configuration with optimal Quality weight is determined.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Data selection schemes/

Quantitative response assay

Quantitative response assays are dilution assays based on a quantitative response. Unlike dichotomous response, quantitative response is measured on a continuous scale. Parallel-line assays and slope ratio assays among others are Quantitative response assays.

Navigate through the properties to select or enter settings you require for this Quantitative response 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. It also provides access to the Documentation, Setup, and Analysis sections.

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 or Settings element in the Creatable elements pane to add a Comment or Settings section to the document.

This element has the following attributes:

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

Context:

Top level

Range full

Uses the full dose range for potency calculation. Select the Range partial option from the drop-down list if you do not want to use the full range.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Data selection schemes/Data selection scheme/choice/

Range partial

Uses a partial dose range for potency calculation that begins at Step start and ends at Step stop. Select the Range full option from the drop-down list if you do not want to use a partial range.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Data selection schemes/Data selection scheme/choice/

Ratio of asymptotes (A / D) (nonlinear models)

Use this test for the following models:

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

This element has the following attributes:

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

Context:

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

Reagent

This section allows you to provide information on a reagent. Expand the node to add or view information.

This element has the following attributes:

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

Context:

/Quantitative response assay/Documentation/

Reagent batch/lot number

Enter the reagent batch or lot number, a combination of numbers, letters, and/or symbols. It identifies a batch (or lot), which allows you to infer the production and distribution history.

This element has the following attributes:

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

Context:

/Quantitative response assay/Documentation/Reagent/

Reagent class

Enter the class of the reagent such as the drug class.

This element has the following attributes:

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

Context:

/Quantitative response assay/Documentation/Reagent/

Reagent description

Enter a description of the reagent.

Tip: You can enter multiline text.

This element has the following attributes:

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

Context:

/Quantitative response assay/Documentation/Reagent/

Reagent identification

Enter information to identify the reagent.

This element has the following attributes:

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

Context:

/Quantitative response assay/Documentation/Reagent/

Reagent name

Enter a name for the reagent.

Tip: You can enter a reference to a reagent document instead. Select the Reagent reference option from the drop-down list.

This element has the following attributes:

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

Context:

/Quantitative response assay/Documentation/Reagent/choice/

Reagent reference

Select a reagent document.

Tip: You can enter a reagent name instead. Select the Reagent name option from the drop-down list.

This element has the following attributes:

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

Context:

/Quantitative response assay/Documentation/Reagent/choice/

Reagent sub-batch/sub-lot number

Enter the reagent sub-batch or sub-lot number, a combination of numbers, letters, and/or symbols. It identifies a sub-batch (or sub-lot), which allows you to infer the production and distribution history.

This element has the following attributes:

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

Context:

/Quantitative response assay/Documentation/Reagent/

Reagent variant

Enter the variant of the reagent.

This element has the following attributes:

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

Context:

/Quantitative response assay/Documentation/Reagent/

Recursive

Set Recursive to 'yes' if you want to repeat the test (with previously found outliers excluded) as long as outliers are detected and the number of values is greater than or equal to 3.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Data selection schemes/Data selection scheme/choice/Dixon test/

/Quantitative response assay/Analysis/Data selection schemes/Data selection scheme/choice/Grubbs test/

/Quantitative response assay/Analysis/Data selection schemes/Data selection scheme/choice/(Externally) studentized residuals test/

Reference mean (calculated value)

Select how you want to define the reference mean of the parameter. The reference mean is used as scaling parameter in the test.

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

  • Calculated value: Selects the corresponding mean from your development assays.
  • Manual input: Allows you to enter a decimal number to set the reference mean manually.

This element has the following attributes:

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

Context:

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Scaled parameter range/Upper asymptote (A) (nonlinear models)/choice/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Scaled parameter range/B parameter (nonlinear models)/choice/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Scaled parameter range/C parameter (nonlinear models)/choice/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Scaled parameter range/Lower asymptote (D) (nonlinear models)/choice/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Scaled parameter range/Asymmetry parameter (G) (nonlinear models)/choice/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Scaled parameter range/Slope (linear models)/choice/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Scaled parameter range/Intercept (linear models)/choice/

Reference mean (manual input)

Select how you want to define the reference mean of the parameter. The reference mean is used as scaling parameter in the test.

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

  • Calculated value: Selects the corresponding mean from your development assays.
  • Manual input: Allows you to enter a decimal number to set the reference mean manually.

This element has the following attributes:

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

Context:

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Scaled parameter range/Upper asymptote (A) (nonlinear models)/choice/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Scaled parameter range/B parameter (nonlinear models)/choice/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Scaled parameter range/C parameter (nonlinear models)/choice/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Scaled parameter range/Lower asymptote (D) (nonlinear models)/choice/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Scaled parameter range/Asymmetry parameter (G) (nonlinear models)/choice/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Scaled parameter range/Slope (linear models)/choice/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Scaled parameter range/Intercept (linear models)/choice/

Relative potency

This column displays the combined relative potency.

This element has the following attributes:

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

/Basic bioassay protocol/Reportable values/

/Combination of independent assay results/Setup/Potency data/

Relative potency lower confidence limit

This column displays the lower confidence limit of the combined relative potency.

This element has the following attributes:

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

/Basic bioassay protocol/Reportable values/

/Combination of independent assay results/Setup/Potency data/

Relative potency status

This column indicates the test status of the combined relative potency.

This element has the following attributes:

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

Context:

/Basic bioassay protocol/Reportable values/

Relative potency upper confidence limit

This column displays the upper confidence limit of the combined relative potency.

This element has the following attributes:

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

/Basic bioassay protocol/Reportable values/

/Combination of independent assay results/Setup/Potency data/

Replicate averaging

Enable this feature if you want to fit the regression by using the mean of the response values for each sequence step rather than individual response values.

Expand the node to add or view information.

This element has the following attributes:

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

Context:

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

Replicate count

Enter a number to specify how many replicates this assay element requires for each dose step.

This element has the following attributes:

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

Context:

/Quantitative response assay/Setup/Preparation schemes/Preparation scheme/

Report excluded/invalid elements

Select the 'yes' option from the drop-down list to have invalid and excluded assay elements reported and made available for use in subsequent documents (such as Combination of assay results documents).

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Analytical model/Advanced settings/

Reportable values

This section allows you to adjust the dataset structure used to summarize reportable values generated by Combination of assay results documents.

This element has the following attributes:

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

Context:

/Basic bioassay protocol/

Response data processing

This section allows you to define how your response data is to be processed prior to fitting the regression model. You set up a sequence of response data processing steps. PLA executes response data processing steps in the order they are displayed in this section, from top to bottom. Drag and drop individual steps to change the sequence.

Four types of response data processing are available:

  • Adjustment
  • Normalization
  • Transformation
  • Replicate averaging
Tip: You can add multiple Adjustment and multiple Normalization steps from the Creatable elements pane. But you can only use one Transformation and one Replicate averaging step.

By default, four response data processing steps are displayed - one of each type. By default, all four steps are deactivated. Activate the steps you require.

Tip: Add a scope element to individual Adjustment, Normalization, and Transformation steps. This allows you to apply individual steps to specific Assay elements, Assay element types, or Plates.

Expand the node to add or view information.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/

Response maximum

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

This element has the following attributes:

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

Context:

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

Response minimum

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

This element has the following attributes:

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

Context:

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

Response range

Defines the least and greatest value of the y-axis used for simulation plots.

Note: These values only apply if no assays are referenced. Otherwise, the values of the referenced assays are used.

This element has the following attributes:

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

Context:

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

Response value lower limit

Enter a number to specify the lower limit you want to use.

Response values that are less than the lower limit you enter are treated as technical outliers and therefore excluded from analysis. Response values that are equal to the limit are included.

Note: Set the limit to 0 if you want to maintain backward compatibility with PLA 1.x and 2.0. This is not required for PLA 2.1.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Analytical model/

Response value upper limit

Enter a number to specify the upper limit you want to use.

Response values that are greater than the upper limit you enter are treated as technical outliers and therefore excluded from analysis. Response values that are equal to the limit are included.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Analytical model/

Restrict selection

Select the Use identical dose steps option to only include configurations that have the same number of dose steps. To only include configurations whose Test sample has the same number of dose steps as the Standard sample, select the Use equal number of dose steps option. To include all configuration, select the No restrictions option.

Note: If you do not use simultaneous regression, this condition applies to individual Standard-vs-Test sample or Standard-vs-Control sample pairs. With simultaneous regression, this condition applies to all assay elements except Control lines.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Data selection schemes/Data selection scheme/choice/Optimization on/

Role

Enter the role of the operator.

This element has the following attributes:

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

/Basic bioassay protocol/Documentation/Operator/

/Combination of independent assay results/Documentation/Operator/

/Quantitative response assay/Documentation/Operator/

Rounding

Apply a Rounding setting to have the test round values prior to evaluation.

Rounded values are compared to the full-precision margins, critical values, or p-values used in the test.

The following options are available:

  • No rounding
  • x decimal places (where x is an integer from 0 to 10)
Note: The rounding method 'half away from zero' is used.

Rounding examples for the '0 decimal places' option:

Test result Observed value Lower margin Upper margin Rounded value
Passed because 0.0 ≤ 1.0 ≤ 1.0 0.5113 0.0 1.0 1.0
Passed because -1.0 ≤ -1.0 ≤ 0.0 -0.5113 -1.0 0.0 -1.0
Failed because 1.0 ≥ 0.6 0.5113 0.0 0.6 1.0
Note: You may need this feature to follow protocol procedures or company regulations. We do not recommend to use rounding for test evaluation.

This element has the following attributes:

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

Context:

/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 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 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 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 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)/

Rounding

Apply a Rounding setting to have the test round values prior to evaluation. Rounded values are compared to the full-precision margins, critical values, or p-values used in the test.

Note: You may need this feature to follow protocol procedures or company regulations. We do not recommend to use rounding for test evaluation.

The following options are available:

  • No rounding
  • x decimal places (where x is an integer from 0 to 10)
Note: The rounding method 'half away from zero' is used.

This element has the following attributes:

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

Context:

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Coefficient of variation (%)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Geometric coefficient of variation (%)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Log potency range (L-value)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Mean coefficient of variation (%)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Potency spread (%)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Sum of weights/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Combined log potency confidence interval width (L-term)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Combined potency confidence interval/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Combined potency confidence interval (%)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Combined potency confidence interval range (%)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Combined potency value/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Homogeneity/

Row order

Select the sort order you want to apply to the data rows.

This element has the following attributes:

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

/Basic bioassay protocol/Reportable values/

/Combination of independent assay results/Setup/Potency data/

/Equivalence margin development (Quantitative response assays)/Data table/

/Quantitative response assay/Setup/Observation data/

Sample suitability tests

Add the Sample suitability tests you require.

The results of Sample suitability tests just affect the individual Standard-vs-Test sample comparison for which they are set rather than the whole assay document.

Note: With simultaneous regression (formerly called multiplex assay), there is no difference in how Assay suitability tests and Sample suitability tests are evaluated.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Suitability tests/

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

Scaling parameter

Enter the Scaling parameter of the test as positive decimal number.

The observed confidence interval is divided by the scaling parameter prior to being compared to the margins.

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

This element has the following attributes:

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

Context:

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

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

/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/Sample suitability tests/choice/Equivalence test: Scaled parameter range/

Scope of the test

Select which part of the document is to be signed. The following options are available from the drop-down list:

  • Content: The test only counts signatures that confirm content of the document (all content except dataset).
  • Data: The test only counts signatures that confirm observations of the document.

This element has the following attributes:

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

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Signature status/

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

Context:

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

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

Scope of the test

Select the assay elements to be tested for assay verification.

Which assay elements are included in a test also depends on the test type. Some tests are only performed for particular types of assay elements. Moreover, the model determines which tests are feasible. Some test definitions may not work with your model.

Important: Test definitions are ignored without notification if the scope you select results in invalid test definitions (for example, if a test cannot be performed for the assay element type you select).

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

  • All assay elements: Runs the test for every assay element.
  • Standard only: Runs the test for the Standard sample.
  • Test/Control samples only: Runs the test for every Test and Control sample.
Note: This property does not affect margin development, which always uses the values of the Standard samples.

Please consult the help pages of particular tests for additional information.

This element has the following attributes:

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

Context:

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Parameter estimate/Upper asymptote (A) (nonlinear models)/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Parameter estimate/B parameter (nonlinear models)/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Parameter estimate/C parameter (nonlinear models)/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Parameter estimate/Lower asymptote (D) (nonlinear models)/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Parameter estimate/Asymmetry parameter (G) (nonlinear models)/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Parameter estimate/Slope (linear models)/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Parameter estimate/Intercept (linear models)/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Parameter estimate/Difference of asymptotes (A - D) (nonlinear models)/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Equivalence tests: Parameter estimate/Ratio of asymptotes (A / D) (nonlinear models)/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Point estimate tests: Parameter estimate/Upper asymptote (A) (nonlinear models)/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Point estimate tests: Parameter estimate/B parameter (nonlinear models)/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Point estimate tests: Parameter estimate/C parameter (nonlinear models)/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Point estimate tests: Parameter estimate/Lower asymptote (D) (nonlinear models)/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Point estimate tests: Parameter estimate/Asymmetry parameter (G) (nonlinear models)/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Point estimate tests: Parameter estimate/Slope (linear models)/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Point estimate tests: Parameter estimate/Intercept (linear models)/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Point estimate tests: Parameter estimate/Slope (nonlinear models)/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Point estimate tests: Parameter estimate/Difference of asymptotes (A - D) (nonlinear models)/

/Equivalence margin development (Quantitative response assays)/Test strategies/Strategy/Point estimate tests: Parameter estimate/Ratio of asymptotes (A / D) (nonlinear models)/

Scope of the test

Select the Scope of the test.

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

  • Relative potency: The test is performed for the relative potency combination calculation.
  • Absolute potency: The test is performed for the absolute potency combination calculation.

This element has the following attributes:

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

Context:

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Coefficient of variation (%)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Geometric coefficient of variation (%)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Log potency range (L-value)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Mean coefficient of variation (%)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Number of invalid assays/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Number of valid assays/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Potency spread (%)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Sum of weights/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Combined log potency confidence interval width (L-term)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Combined potency confidence interval/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Combined potency confidence interval (%)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Combined potency confidence interval range (%)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Combined potency value/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Homogeneity/

Second response column

Select the Column: Response value in the observation data table you want to subtract from the values of the First response column.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Response data processing/Difference of responses/

Section key

Enter a Section key to restrict the data to the section identified by the key.

Note: The key only applies to document aggregation.

This element has the following attributes:

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

/Basic bioassay protocol/Reportable values/Document reference/Section property filter/

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

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

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

Section key

Enter a Section key to restrict the data to the section identified by the key.

This element has the following attributes:

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

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

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

/Combination of independent assay results/Comment/Linked document/Config/Section property filter/

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

/Quantitative response assay/Comment/Linked document/Config/Section property filter/

/Test system definition (Quantitative response assay)/Comment/Linked document/Config/Section property filter/

Section property filter

Currently, no information available.

This element has the following attributes:

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

Context:

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

Section property filter

Define a filter based on a section property to require referenced documents match this property.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...unbounded 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/

Section property import

Define the section property you want to import.

This element has the following attributes:

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

/Basic bioassay protocol/Comment/Linked document/Config/

/Combination of independent assay results/Comment/Linked document/Config/

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

/Quantitative response assay/Comment/Linked document/Config/

/Test system definition (Quantitative response assay)/Comment/Linked document/Config/

Selected method

This column indicates the combination method selected.

This element has the following attributes:

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

Context:

/Basic bioassay protocol/Reportable values/

Settings

This section allows you to enable and disable development, verification, and visualization. You can also set confidence and tolerance levels.

Expand the node to add or view information.

This element has the following attributes:

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

Context:

/Equivalence margin development (Quantitative response assays)/

Settings

This section allows you to adjust various settings.

Expand the node to add or view information.

This element has the following attributes:

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

Context:

/Quantitative response assay/

Setup

This section allows you to set up this assay. It provides the following features:

  • Assay elements: Details all assay elements, that is, Standard sample, Test samples, Control samples, and Control lines.
  • Preparation schemes: Defines Preparation schemes including dose sequences.
  • Observation data: Sets up the observation data table. The table is created automatically based on information provided on assay elements and preparation schemes. But you can set up additional data columns such as the Position factor column.

Expand the node to add or view information.

This element has the following attributes:

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

Context:

/Quantitative response assay/

Setup

This section allows you to set up the dataset.

Expand the node to add or view information.

This element has the following attributes:

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

Context:

/Combination of independent assay results/

Severity level of the test

Select the Severity level of the test. The severity level controls how failed tests affect assay results.*

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

  • Reject: If the test fails, no potencies are reported. For reporting the overall test result, the test is considered 'Rejected'.
  • If the test fails, potencies are reported. For reporting the overall test result, the test is considered 'Failed'.
  • Information: If the test fails, potencies are reported. For reporting the overall test result, the test is considered 'Passed' (info available).

PLA 3.0 determines an overall test result from the severity levels of failed tests, as indicated in the following table:

Overall test result Failed tests of severity level 'Rejected' Failed tests of severity level 'Warning' Failed tests of severity level 'Information'
Passed 0 0 0
Passed (info available) 0 0 ≥1
Failed 0 ≥1 any number
Rejected ≥1 any number any number
Note: If tests cannot be calculated and return 'not calculated' (NC) results (for example, if Fieller's formula is needed to calculate test results and computed values are outside the valid range), the behavior of the test system depends on your settings in Test exception handling. Please consult the help pages on Test exception handling for additional information.

* The term 'assay' here refers to calculations for individual sample pairs (Test sample compared to Standard) unless simultaneous regression (formerly called multiplex assay) is used. If a test is set up as an Assay suitability test, it also counts for calculations of the overall test results of other sample pairs in the assay document.

This element has the following attributes:

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

Context:

/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)/

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

Context:

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

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

/Quantitative response assay/Analysis/Suitability tests/Document suitability tests/Test on user variable/

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

Severity level of the test

Select the Severity level of the test. The severity level controls how failed tests affect combination results.

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

  • Reject: If the test fails, no combined potencies are reported. For reporting the overall test result, the test is considered 'Rejected'.
  • If the test fails, potencies are reported. For reporting the overall test result, the test is considered 'Failed'.
  • Information: If the test fails, potencies are reported. For reporting the overall test result, the test is considered 'Passed' (info available).

PLA 3.0 determines an overall test result from the severity levels of failed tests, as indicated in the following table:

Overall test result Failed tests of severity level 'Rejected' Failed tests of severity level 'Warning' Failed tests of severity level 'Information'
Passed 0 0 0
Passed (info available) 0 0 ≥1
Failed 0 ≥1 any number
Rejected ≥1 any number any number
Note: In some cases, tests cannot be calculated (for example, if Fieller's formula is needed to calculate test results and computed values are outside the valid range). Tests are then reported as 'NC' and are not used in the calculation of the overall test result.

This element has the following attributes:

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

Context:

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Coefficient of variation (%)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Geometric coefficient of variation (%)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Log potency range (L-value)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Mean coefficient of variation (%)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Number of invalid assays/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Number of valid assays/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Potency spread (%)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Sum of weights/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Combined log potency confidence interval width (L-term)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Combined potency confidence interval/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Combined potency confidence interval (%)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Combined potency confidence interval range (%)/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Combined potency value/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Homogeneity/

/Combination of independent assay results/Analysis/Suitability tests/choice/Test: Signature status/

Signature state

Add one or several tests for the signature state to your assay. You must select a scope and a severity level for the test from the drop-down lists.

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

This element has the following attributes:

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

Context:

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

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

Significance level (homogeneity test)

Select the significance level of the Chi-square test of homogeneity.

This element has the following attributes:

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

Context:

/Combination of independent assay results/Analysis/choice/Combination type based on homogeneity test/

Simulation space

Define the standard errors and covariances for the simulation of model parameters. For each parameter, simulation samples a value from the uniform distribution within given limits.

The default settings are as follows:

  • If no Standard error is defined, the mean of the standard errors of the parameter in the referenced assays is used as default.
  • If no Covariances are defined, 0 is used as default.

This element has the following attributes:

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

Context:

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

Simultaneous regression

Specifies how the assay is to be evaluated.

Set Simultaneous regression to 'yes' if all samples are to be regarded as one single dataset and approximated together.

Note: If you combine configuration optimization with simultaneous regression, you create a very large number of configurations. Your system may not be able to calculate all configurations in a timely manner.

Set Simultaneous regression to 'no' if the samples are to be regarded as a collection of Standard-vs-Test comparisons with each pair approximated separately.

Note: Simultaneous regression is referred to as 'multiplex assay' in previous versions of our software.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Analytical model/

Slope (linear models)

This parameter is used for the following models:

  • Linear parallel-line model
  • Slope ratio model

This element has the following attributes:

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

Context:

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

Slope (linear models)

Use this test for the following models:

  • Linear parallel-line model
  • Slope ratio model

This element has the following attributes:

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

Context:

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

Slope (nonlinear models)

Use this test for the following models:

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

This element has the following attributes:

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

Context:

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

Solvent (summary)

Expand the node to add or view information.

This element has the following attributes:

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

/Basic bioassay protocol/choice/Mode: Assay element/Standard sample/choice/Absolute potency: Defined by raw material/

/Basic bioassay protocol/choice/Mode: Assay element/Test sample/choice/Absolute potency: Defined by raw material/

/Basic bioassay protocol/choice/Mode: Assay element/Control sample/choice/Absolute potency: Defined by raw material/

/Quantitative response assay/Setup/Preparation schemes/Preparation scheme/choice/Absolute potency: Defined by raw material/

Solvent volume

Enter the volume of the solvent.

This element has the following attributes:

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

/Basic bioassay protocol/choice/Mode: Assay element/Standard sample/choice/Absolute potency: Defined by raw material/Solvent (summary)/

/Basic bioassay protocol/choice/Mode: Assay element/Test sample/choice/Absolute potency: Defined by raw material/Solvent (summary)/

/Basic bioassay protocol/choice/Mode: Assay element/Control sample/choice/Absolute potency: Defined by raw material/Solvent (summary)/

/Quantitative response assay/Setup/Preparation schemes/Preparation scheme/choice/Absolute potency: Defined by raw material/Solvent (summary)/

Solvent volume units

Enter the unit for solvent volume.

This element has the following attributes:

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

/Basic bioassay protocol/choice/Mode: Assay element/Standard sample/choice/Absolute potency: Defined by raw material/Solvent (summary)/

/Basic bioassay protocol/choice/Mode: Assay element/Test sample/choice/Absolute potency: Defined by raw material/Solvent (summary)/

/Basic bioassay protocol/choice/Mode: Assay element/Control sample/choice/Absolute potency: Defined by raw material/Solvent (summary)/

/Quantitative response assay/Setup/Preparation schemes/Preparation scheme/choice/Absolute potency: Defined by raw material/Solvent (summary)/

Source

Links this document to the source Equivalence margin development document.

This element has the following attributes:

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

Context:

/Test system definition (Quantitative response assay)/

Square response transformation

Performs a square transformation of your response values. By default, the transformation you select is applied to every response value.

Tip: If you require a different transformation, select the corresponding option from the drop-down list.

This element has the following attributes:

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

Context:

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

Square root response transformation

Performs a square root transformation of your response values. By default, the transformation you select is applied to every response value.

Tip: If you require a different transformation, select the corresponding option from the drop-down list.

This element has the following attributes:

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

Context:

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

Standard deviation test

Provides a statistical outlier detection method based on multiples of the standard deviation.

The test is based on replicates. Therefore, no outliers are detected for dose steps with less than three observations.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Data selection schemes/Data selection scheme/choice/

Standard error

Enter a decimal number to specify the standard error of the parameter. It is used during simulation to calculate confidence intervals if required by a test.

This element has the following attributes:

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

Context:

/Equivalence margin development (Quantitative response assays)/Visualization/Simulation space/Upper asymptote (A) (nonlinear models)/

/Equivalence margin development (Quantitative response assays)/Visualization/Simulation space/B parameter (nonlinear models)/

/Equivalence margin development (Quantitative response assays)/Visualization/Simulation space/C parameter (nonlinear models)/

/Equivalence margin development (Quantitative response assays)/Visualization/Simulation space/Lower asymptote (D) (nonlinear models)/

/Equivalence margin development (Quantitative response assays)/Visualization/Simulation space/Asymmetry parameter (G) (nonlinear models)/

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

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

Standard sample

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

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.

This element has the following attributes:

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

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

/Quantitative response assay/Setup/Assay elements/

Step start

Enter a step number to specify the first step of the partial range.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Data selection schemes/Data selection scheme/choice/Range partial/

Step stop

Enter a step number to specify the last step of the partial range.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Data selection schemes/Data selection scheme/choice/Range partial/

Stepwise dilution sequence

Allows you to define a sequence by specifying the Dilution factor of each step individually. Select a different sequence type from the drop-down list if you require.

To add a sequence step: Double-click Dilution factor in the Creatable elements pane.

Note: If you add an Initial value element to define the first step in this sequence, the value you enter overrides the value implied by the predilution factors of this preparation scheme and the settings of referencing assay elements. Please consult the help page on the Initial value element for additional information.

This element has the following attributes:

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

Context:

/Quantitative response assay/Setup/Preparation schemes/Preparation scheme/choice/

Strategy

Defines a collection of tests and corresponding margins.

Note: You can use development and verification data to evaluate test strategies.

Select developed margins or enter margins manually for each test. Please consult the help pages of particular tests for additional information.

Tip: Visualize test strategies. Please consult the Visualization section for additional information.

This element has the following attributes:

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

Context:

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

Subject

Enter the subject of this comment.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:token 0...1 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/

Substance batch/lot number

Enter the substance batch or lot number, a combination of numbers, letters, and/or symbols. It identifies a batch (or lot), which allows you to infer the production and distribution history.

This element has the following attributes:

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

/Basic bioassay protocol/Documentation/

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

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

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

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

/Combination of independent assay results/Documentation/

/Combination of independent assay results/Documentation/Groups/Group/

/Quantitative response assay/Documentation/

/Quantitative response assay/Setup/Assay elements/Standard sample/

/Quantitative response assay/Setup/Assay elements/Test sample/

/Quantitative response assay/Setup/Assay elements/Control sample/

/Quantitative response assay/Setup/Assay elements/Control line/

Substance class

Enter the class of the substance such as the drug class.

This element has the following attributes:

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

/Basic bioassay protocol/Documentation/

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

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

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

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

/Combination of independent assay results/Documentation/

/Combination of independent assay results/Documentation/Groups/Group/

/Quantitative response assay/Documentation/

/Quantitative response assay/Setup/Assay elements/Standard sample/

/Quantitative response assay/Setup/Assay elements/Test sample/

/Quantitative response assay/Setup/Assay elements/Control sample/

/Quantitative response assay/Setup/Assay elements/Control line/

Substance description

Enter a description of the substance.

Tip: You can enter multiline text.

This element has the following attributes:

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

/Basic bioassay protocol/Documentation/

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

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

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

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

/Combination of independent assay results/Documentation/

/Combination of independent assay results/Documentation/Groups/Group/

/Quantitative response assay/Documentation/

/Quantitative response assay/Setup/Assay elements/Standard sample/

/Quantitative response assay/Setup/Assay elements/Test sample/

/Quantitative response assay/Setup/Assay elements/Control sample/

/Quantitative response assay/Setup/Assay elements/Control line/

Substance identification

Enter information to identify the substance.

This element has the following attributes:

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

/Basic bioassay protocol/Documentation/

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

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

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

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

/Combination of independent assay results/Documentation/

/Combination of independent assay results/Documentation/Groups/Group/

/Quantitative response assay/Documentation/

/Quantitative response assay/Setup/Assay elements/Standard sample/

/Quantitative response assay/Setup/Assay elements/Test sample/

/Quantitative response assay/Setup/Assay elements/Control sample/

/Quantitative response assay/Setup/Assay elements/Control line/

Substance name

Enter a name for the substance.

Tip: You can enter a reference to a substance document instead. Select the Substance reference option from the drop-down list.

This element has the following attributes:

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

/Basic bioassay protocol/Documentation/choice/

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

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

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

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

/Combination of independent assay results/Documentation/choice/

/Combination of independent assay results/Documentation/Groups/Group/choice/

/Quantitative response assay/Documentation/choice/

/Quantitative response assay/Setup/Assay elements/Standard sample/choice/

/Quantitative response assay/Setup/Assay elements/Test sample/choice/

/Quantitative response assay/Setup/Assay elements/Control sample/choice/

/Quantitative response assay/Setup/Assay elements/Control line/choice/

Substance reference

Select a substance document.

Tip: You can enter a substance name instead. Select the Substance name option from the drop-down list.

This element has the following attributes:

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

/Basic bioassay protocol/Documentation/choice/

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

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

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

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

/Combination of independent assay results/Documentation/choice/

/Combination of independent assay results/Documentation/Groups/Group/choice/

/Quantitative response assay/Documentation/choice/

/Quantitative response assay/Setup/Assay elements/Standard sample/choice/

/Quantitative response assay/Setup/Assay elements/Test sample/choice/

/Quantitative response assay/Setup/Assay elements/Control sample/choice/

/Quantitative response assay/Setup/Assay elements/Control line/choice/

Substance sub-batch/sub-lot number

Enter the substance sub-batch or sub-lot number, a combination of numbers, letters, and/or symbols. It identifies a sub-batch (or sub-lot), which allows you to infer the production and distribution history.

This element has the following attributes:

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

/Basic bioassay protocol/Documentation/

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

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

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

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

/Combination of independent assay results/Documentation/

/Combination of independent assay results/Documentation/Groups/Group/

/Quantitative response assay/Documentation/

/Quantitative response assay/Setup/Assay elements/Standard sample/

/Quantitative response assay/Setup/Assay elements/Test sample/

/Quantitative response assay/Setup/Assay elements/Control sample/

/Quantitative response assay/Setup/Assay elements/Control line/

Substance variant

Enter the variant of the substance.

This element has the following attributes:

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

/Basic bioassay protocol/Documentation/

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

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

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

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

/Combination of independent assay results/Documentation/

/Combination of independent assay results/Documentation/Groups/Group/

/Quantitative response assay/Documentation/

/Quantitative response assay/Setup/Assay elements/Standard sample/

/Quantitative response assay/Setup/Assay elements/Test sample/

/Quantitative response assay/Setup/Assay elements/Control sample/

/Quantitative response assay/Setup/Assay elements/Control line/

Suitability tests

This section allows you define tests on input data and combination results to determine the validity of your combination calculation.

This element has the following attributes:

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

Context:

/Combination of independent assay results/Analysis/

Suitability tests

This section allows you to define the statistical tests you require for this assay document. The tests are organized into the following categories: Assay suitability tests, Sample suitability tests, and Document suitability tests. Expand the node to add or view information.

Note: Suitability tests are required to prove the validity of your assay runs.

Expand the node to add or view information.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/

/Test system definition (Quantitative response assay)/