G–M

Find reference information on document elements of the Biological Assay Package, letters G to M.

Generator key

Enter a document key to require referenced documents be generated by a document that matches the key.

This element has the following attributes:

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

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

/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/

Geometric sequence

Allows you to define an n-fold geometric sequence. That is, each term after the first is found by multiplying the previous by a fixed number. Select a different sequence type from the drop-down list if you require.

The dose value for the j-th step of an n-fold sequence is given by:

Dose j = First Dose ⋅ Base (1 - j)

Example:

Initial value Base 1st step 2nd step 3rd step n-th step
= Initial value = Initial value / Base = Initial value / Base^2 = Initial value / Base^n
1 2 1.0 0.5 0.25 1 * 2^(1-n)
8 2 8.0 4.0 2.0 8* 2^(1-n)
1 0.5 1.0 2.0 4.0 1* (1/2)^(1-n)
5 3 5.0 1.67 0.56 5* 3^(1-n)

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/

Graphics

This section allows you to define how graphs are displayed. Add elements to change the settings for Data plot, Full model, and Restricted model.

This element has the following attributes:

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

Context:

/Quantitative response assay/Settings/

Group

Enter a group name to mark the Test sample for inclusion in a combination calculation. The group only affects combination documents if they reference assay documents that have the group. In this case, all accessible Test samples of the group are included in the combination calculations.

Assay results used in combination calculations are assumed to be independent.

Note: The group does not affect assay calculations.

This element has the following attributes:

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

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

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

Group

This column provides information on the groups intended for combination calculations.

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/

Group

This section allows you to define the details of a group. This information is printed in the report and shown on the dashboard.

This element has the following attributes:

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

Context:

/Combination of independent assay results/Documentation/Groups/

Groups

This section allows you to add groups. A group usually corresponds to a reportable value. Use groups to add information with which to identify the substance to the report.

Note: The group does not affect assay calculations. The actual assignment of Test samples to groups is done in the assay document.

This element has the following attributes:

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

Context:

/Combination of independent assay results/Documentation/

Grubbs test

Provides a statistical test for the detection of data outliers based on: Grubbs, Frank E. 1969. 'Procedures for detecting outlying observations in samples.' Technometrics 11 (1): 1-21.

The test is based on replicates. Therefore, no outliers are detected for dose steps with less than three observations. Sensitivity is defined by the respective alpha value.

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/

Identification

Enter a string to identify this document by this string rather than its name.

Note: We recommend to use unique identification strings. But this is not required.

This element has the following attributes:

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

/Combination of independent assay results/

/Equivalence margin development (Quantitative response assays)/

/Quantitative response assay/

/Test system definition (Quantitative response assay)/

Ignore 50-percent response

Performs configuration optimization without regard to the 50-percent response. This control allows you to specify whether the selected range is to contain the 50-percent response, which is the mean of the minimal step mean and the maximal step mean where the step means are arithmetic means of the response values in single dose sequence steps.

Tip: Select the Include 50-percent response option from the drop-down list if the selected range is to contain the 50-percent response. With this option, additional properties are available.

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/Optimization on/choice/

Import comment

Enter text to provide additional information on the data import.

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/Data source/

Import module identification

Automatically inserts information that allows you to identify the import module used to import data.

This element has the following attributes:

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

Context:

/Quantitative response assay/Documentation/Data source/

Import time stamp

Automatically inserts the current date and time when you import data.

This element has the following attributes:

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

Context:

/Quantitative response assay/Documentation/Data source/

Include 50-percent response

Performs configuration optimization in relation to the 50-percent response. This control allows you to specify whether the selected range is to contain the 50-percent response, which is the mean of the minimal step mean and the maximal step mean where the step means are arithmetic means of the response values in single dose sequence steps.

Note: The minimal response of the selected range is to be less than or equal to the 50-percent response, and the maximal response of the selected range is to be greater than or equal to the 50-percent response.

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/Optimization on/choice/

Include control line

Specifies a Control line to be used in the model fit. Select a Control line from the drop-down list.

Note: The Control line provides additional data, for example, to estimate the upper or lower asymptote in 4-parameter logistic fits or the intercept in slope ratio models.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Analytical model/choice/Model: 4-parameter logistic fit/

/Quantitative response assay/Analysis/Analytical model/choice/Model: Slope ratio/

Initial value

Enter a number to specify the Initial value of this sequence. The number you enter must be a non-negative decimal.

The dose value for the j-th step of an n-fold sequence is given by:

Dose j = First Dose ⋅ Base (1 - j)

This element has the following attributes:

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

Context:

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

Initial value

Enter a number to specify the Initial value of this sequence.The number you enter must be a non-negative decimal.

Important: If the value you enter here differs from values implied by the predilution factors of this preparation scheme and the settings of referencing assay elements, the analysis uses the value you enter here, and the system returns a warning message and provides the discrepancy as Implicit factor in reports.

This element has the following attributes:

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

Context:

/Quantitative response assay/Setup/Preparation schemes/Preparation scheme/choice/Stepwise dilution sequence/

Intercept (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/

Intercept (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/

Invert potency

Select the 'yes' option from the drop-down list to have the potency ratio inverted.

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/Advanced settings/

Key

Enter a key to identify the user variable.

This element has the following attributes:

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

Context:

/Combination of independent assay results/Documentation/User variable/

Key

Enter a key to identify the user variable. To make the user variable available for data aggregation, the key should not exceed 400 characters. Longer keys are shortened automatically and may become unreadable.

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

This element has the following attributes:

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

Context:

/Quantitative response assay/Documentation/User variable/

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

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

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

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

Key

Enter the key of a user variable for the test.

This element has the following attributes:

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

Context:

/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/

Label of the x-axis

Enter a name for the x-axis.

This element has the following attributes:

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

Context:

/Quantitative response assay/Settings/Graphics/

Label of the y-axis

Enter a name for the y-axis.

This element has the following attributes:

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

Context:

/Quantitative response assay/Settings/Graphics/

Linear sequence

Allows you to define a linear sequence, that is, each term after the first is found by adding a fixed number to the previous. Select a different sequence type from the drop-down list if you require.

The dose value for the j-th step of a linear sequence is given by:

Dose j = First Dose + Delta ⋅ (j - 1)

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/

Linked document

Select a document.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 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/

Logarithm base

Select the logarithm to be used for transforming your response values.

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

  • Binary logarithm (base 2)
  • Natural logarithm (base e)
  • Decimal logarithm (base 10)

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/choice/Transformation/choice/Logarithmic response transformation/

Logarithm base

Select the logarithm base you require for visualization.

Note: This selection only applies if no assays are referenced. Otherwise, the logarithm base of the referenced assays is used.

This element has the following attributes:

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

Context:

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

Logarithm base

Specifies the logarithm base to be used for dose transformation. The following options are available from the drop-down list:

  • Binary logarithm (base 2)
  • Natural logarithm (base e)
  • Decimal logarithm (base 10)

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/Advanced settings/

Logarithm type

Select the logarithm type, also referred to as the logarithm base.

This element has the following attributes:

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

Context:

/Combination of independent assay results/Analysis/

Logarithmic response transformation

Select an option from the 'Logarithm base' drop-down list below to specify the logarithm to be used for transforming 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
Node 1...1 required none

Context:

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

Lower asymptote (D) (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

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/

Lower asymptote (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/

Lower margin

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

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/Test: Minimal R²/

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

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

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

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

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

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

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

Lower margin

Enter the Lower margin of the test as decimal number. The Lower margin must be less than or equal to the Upper margin of the test.

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.

This element has the following attributes:

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

Context:

/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/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: 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: Response value range/

/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/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: 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: Response value range/

/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/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: 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: Response value range/

/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/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: 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: Response value range/

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

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

/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/Sample suitability tests/choice/Test: Maximal sequence step CV (%)/

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

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

/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/

Lower margin

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

Note: The system permits equal values for upper and lower margin.

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

This element has the following attributes:

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

Context:

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

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

Context:

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

/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: Sum of weights/

Lower margin

Enter the Lower margin of the test as a positive integer. To pass the test, the observed value must be greater than or equal to the Lower margin.

Note: The system permits equal values for upper and lower margin.

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

This element has the following attributes:

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

Context:

/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/

Lower margin (calculated value)

Select how you want to define the lower margin of the test. The following options are available from the drop-down list:

  • Calculated value: Selects the corresponding lower margin from the margins you developed.
  • Manual input: Allows you to enter a decimal number to set the lower margin 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: Parameter estimate/Upper asymptote (A) (nonlinear models)/choice/

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Lower margin (manual input)

Select how you want to define the lower margin of the test. The following options are available from the drop-down list:

  • Calculated value: Selects the corresponding lower margin from the margins you developed.
  • Manual input: Allows you to enter a decimal number to set the lower margin 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: Parameter estimate/Upper asymptote (A) (nonlinear models)/choice/

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Map index to characters

Maps the position index to characters (index 1 is mapped to 'A', index 2 is mapped to 'B', ...).

This element has the following attributes:

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

Context:

/Quantitative response assay/Setup/Observation data/Column: Position factor/

Margin development

Select the 'yes' option from the drop-down list to use the development assays to develop margins.

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)/Settings/

Margin development

This section allows you to select the tests for which you want to develop margins.

Note: Tests you remove from the Margin development section also become unavailable for Test strategies and Visualization.

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)/

Margin symmetry assumption

Select the 'yes' option from the drop-down list to enforce developed margins to be symmetrical to 0.

Note: Enforcing margin symmetry results in wider margins.

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)/Margin development/Equivalence tests: Difference of parameter estimates/

Margin symmetry assumption

Select the 'yes' option from the drop-down list to enforce developed margins to be symmetrical to 1.

Note: Enforcing margin symmetry results in wider margins.

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)/Margin development/Equivalence tests: Ratio of parameter estimates/

Max configurations

Model parameters are simulated and tested for the Standard sample until one of the following occurs:

  • The number of valid configurations found for the Standard sample reaches the number set in Max configurations.
  • The number of simulations performed reaches the number set in Max simulations.

Model parameters are simulated and tested for each Standard sample configuration found until one of the following occurs:

  • A valid Test sample configuration is found.
  • The number of simulations performed reaches the number set in Max simulations.

This element has the following attributes:

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

Context:

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

Max simulations

Model parameters are simulated and tested for the Standard sample until one of the following occurs:

  • The number of valid configurations found for the Standard sample reaches the number set in Max configurations.
  • The number of simulations performed reaches the number set in Max simulations.

Model parameters are simulated and tested for each Standard sample configuration found until one of the following occurs:

  • A valid Test sample configuration is found.
  • The number of simulations performed reaches the number set in Max simulations.

This element has the following attributes:

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

Context:

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

Maximal group number

The Maximal group number limits the number of observation groups (assay elements) for which the Observations editor can display data.

This element has the following attributes:

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

Context:

/Quantitative response assay/Setup/Observation data/Column: Observation group/

Meaning

Enter text to specify the signatures this document requires. If you enter a Meaning, the test only accepts and counts signatures that match this Meaning.

Tip: You can enter multiline text.

This element has the following attributes:

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

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

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

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

Minimal number of steps

Enter a number to evaluate configurations that have at least this number of steps.

Tip: Select the Exact number of steps option from the drop-down list if you require.

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/Optimization on/choice/

Mode: Assay element

The Basic bioassay protocol supports two protocol modes, that is, Assay replicate and Assay element.

Use the Assay element mode to define assay elements (Standard sample, Test samples, Control samples, and Control lines) in the Basic bioassay protocol.

Use the Assay replicate mode to generate assay replicate documents based on Quantitative response assay templates.

Tip: You can specify several Quantitative response assay templates to generate a range of assay replicate documents.
Note: Combination of assay results calculations aggregate all Test sample data that result from calculating the assay replicate documents generated by the Basic bioassay protocol.

This element has the following attributes:

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

Context:

/Basic bioassay protocol/choice/

Mode: Assay replicate

Basic bioassay protocols support two protocol modes, that is, Assay replicate and Assay element.

Use the Assay replicate mode to generate assay replicate documents based on Quantitative response assay templates. Combination of assay results calculations aggregate all Test sample data that result from calculating the assay replicate documents generated by the Basic bioassay protocol.

Specify several Quantitative response assay templates to generate a range of assay replicate documents.

Tip: To define assay elements (Standard sample, Test samples, Control samples, and Control lines) in the Basic bioassay protocol, use the Assay element mode.

This element has the following attributes:

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

Context:

/Basic bioassay protocol/choice/

Model

Select the model you require for visualization.

Note: This selection only applies if no assays are referenced. Otherwise, the model of the referenced assays is used.

This element has the following attributes:

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

Context:

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

Model: 3-parameter logistic fit with fixed lower asymptote

Uses the 3-parameter logistic fit regression model with fixed lower asymptote to estimate relative potency.

The model is defined by the following equation:

Response = fixed value + A - fixed value 1 + b - B ⋅ ( log b ( Dose ) - C)

Select a different model from the drop-down list if you require.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Analytical model/choice/

Model: 3-parameter logistic fit with fixed upper asymptote

Uses the 3-parameter logistic fit regression model with fixed upper asymptote to estimate relative potency.

The model is defined by the following equation:

Response = D + fixed value - D 1 + b - B ⋅ ( log b ( Dose ) - C)

Select a different model from the drop-down list if you require.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Analytical model/choice/

Model: 4-parameter logistic fit

Uses the 4-parameter logistic fit regression model to estimate relative potency.

The model is defined by the following equation:

Response = D + A - D 1 + b - B ⋅ ( log b ( Dose ) - C)
Tip: Use the Include control line option from the context menu or Creatable elements pane to add a previously defined Control line to your regression model. The values of the Control line are then used to calculate the upper or lower margin.

Select a different model from the drop-down list if you require.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Analytical model/choice/

Model: 5-parameter logistic fit

Uses the 5-parameter logistic fit regression model to estimate relative potency.

The model is defined by the following equation:

Response = D + A - D 1 + b - B ⋅ ( log b ( Dose ) - C) G

Select a different model from the drop-down list if you require.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Analytical model/choice/

Model: Linear parallel-line

Uses the Linear parallel-line regression model to estimate relative potency.

The model is defined by the following equation:

Response = Slope ⋅ log b ( Dose ) + Intercept

Select a different model from the drop-down list if you require.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Analytical model/choice/

Model: Slope ratio

Uses the Slope ratio regression model to estimate relative potency.

The model is defined by the following equation:

Response = Dose ⋅ Dose + Intercept

Select a different model from the drop-down list if you require.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Analytical model/choice/