A–B

Find reference information on document elements of the Biological Assay Package, letters A to B.

Absolute potency

This column displays the combined 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/

Absolute potency: Defined by raw material

Select this option if you want to start from a raw material to calculate the absolute potency. You specify the absolute potency per amount unit, the amount used for the preparation, and the volume of the solvent. Expand the node to add or view information.

The estimated absolute potency AP_TST of the Test sample is calculated as follows:

AP_TST = RP ⋅ AP_STD ⋅ A_STD ⋅ SV_TST A_TST ⋅ SV_STD

Where RP is the calculated relative potency, AP_STD is the assigend potency of the Standard sample, A_STD is the amount of the Standard sample, SV_TST is the solvent volume of the Test sample, A_TST is the amount of the Test sample, and SV_STD is the solvent volume of the Standard sample.

Tip: Select a different option from the drop-down list if you want to define absolute potency by stock solution or if you do not want to define it.

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/

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

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

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

Absolute potency: Defined by stock solution

Select this option if you want to provide the absolute potency directly. A calculation for absolute potency is performed.

The estimated absolute potency AP_TST of the Test sample is calculated as follows:

AP_TST = RP ⋅ AP_STD

Where RP is the calculated relative potency, and AP_STD is the assigend potency of the Standard sample.

Tip: Select a different option from the drop-down list if you want to define absolute potency by raw material or if you do not want to define it.

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/

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

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

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

Absolute potency: Defined by template

Select this option if you want to use the assay template settings to define absolute potency.

Note: If you do not use this option, the settings provided in the Basic bioassay protocol are used for absolute potency in the generated assay replicates.

This element has the following attributes:

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

Context:

/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/

Absolute potency lower confidence limit

This column displays the lower confidence limit of the 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/

Absolute potency: Not defined

This option does not define an absolute dose for the assay element. No calculation for absolute potency is performed.

Tip: Select a different option from the drop-down list if you want to define absolute potency.

This element has the following attributes:

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

/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/

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

Absolute potency status

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

This element has the following attributes:

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

Context:

/Basic bioassay protocol/Reportable values/

Absolute potency unit

This column indicates the potency unit.

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/

Absolute potency upper confidence limit

This column displays the upper confidence limit of the 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/

Activated

Select the Deactivated option from the drop-down list to disable Replicate averaging.

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/Replicate averaging/choice/

Additional tests

Select the additional tests for which you want to develop margins.

This element has the following attributes:

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

Context:

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

Additional tests

Select the additional tests you want to use to define your test strategy.

This element has the following attributes:

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

Context:

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

Adjustment

Adjust your response values by Fixed value, Control line, or Block-based by Control line.

Example: Use this feature to subtract the absorbance of blank wells.

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/

Advanced settings

This section provides additional settings for assay calculation.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Analytical model/

Allow subfolder

Select the 'true' option from the drop-down list to require referenced documents be elements of the specified folder or one of its subfolders. Otherwise, subfolders are excluded.

Note: The Allow subfolder setting only applies if you also specify a folder in the Folder key element.

This element has the following attributes:

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

/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/

Allow subfolders

Select the 'true' option from the drop-down list to require referenced documents be elements of the specified folder or one of its subfolders. Otherwise, subfolders are excluded.

Note: The Allow subfolders setting only applies if you also specify a folder in the Folder key element.

This element has the following attributes:

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

/Basic bioassay protocol/Reportable values/Document reference/

/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/

Alpha

Select the alpha value you require for this test. The alpha value controls the false positive rate of the test.

Note: Higher values of alpha make the test more sensitive.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:double 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/

Amount

Enter the amount of the substance.

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/Amount (summary)/

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

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

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

Context:

/Quantitative response assay/Documentation/Reagent/

Amount (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/

Amount units

Enter the unit for amount to be used in reporting.

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/Amount (summary)/

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

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

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

Analysis

This section allows you to specify the Analytical model (regression), Data selection schemes (configuration optimization, outlier detection), and Suitability tests (statistical tests) to be used in calculations.

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

This section allows you to specify the Combination type, Compendial guidance, Potency type, Logarithm type, and the Suitability tests to be used in calculations.

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:

/Combination of independent assay results/

Analytical model

This section allows you to specify the analytical model to be used for all assay elements.

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/

ANOVA block effects

Considers block effects when calculating ANOVA. Establish a block design for your observation data by defining up to three block factors. Supported designs are Randomized block design and Latin squares design according to the European Pharmacopoeia. We recommend using a balanced design and not using this feature in combination with outlier detection.

Note: Confoundation is not supported.

This element has the following attributes:

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

Context:

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

ANOVA model

Specifies which ANOVA model is to be used.

Note: The ANOVA model options affect calculation of the parameter standard errors and the error term used in the test on regression, linearity, and parallelism.

The following options are available: Pure-error ANOVA and Residual-error ANOVA.

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/

Assay element scope

Select the assay element you want to include in the test.

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).

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

This element has the following attributes:

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

Context:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Assay element type scope

Select the assay element type you want to include in the test.

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 samples only: Runs the test for every Test sample.
  • Control samples only: Runs the test for every Control sample.

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:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Assay element type scope

Select the assay element type you want to include in the test.

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.
  • Test samples only: Runs the test for every Test sample.
  • Control samples only: Runs the test for every Control sample.

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:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Assay element type scope

Select the assay element type you want to include in the test.

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 samples only: Runs the test for every Test sample.
  • Control samples only: Runs the test for every Control sample.
  • Control lines only: Runs the test for every Control line.

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:

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

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

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

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

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

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

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

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

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

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

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

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

Assay elements

This section allows you to define all assay elements.

Quantitative response assay documents contain four types of assay elements: The Standard sample, Test samples, Control samples, and Control lines. Standard, Test, and Control samples are diluted samples. Control lines may be positive, negative, or blank Control lines that are not diluted.

Add one or several of the following assay elements from the context menu or Creatable elements pane:

  • Test samples: To determine their relative potencies.
  • Control samples: To define additional acceptance criteria.
  • Control lines: To add positive or negative controls.

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/

Assay purpose

Enter text that describes the purpose of this assay.

You can, for example, provide the analyte, identification of the material used, or describe the goal of this analysis.

Tip: You can enter multiline text.

This element has the following attributes:

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

/Combination of independent assay results/Documentation/

/Quantitative response assay/Documentation/

Assay replicate

Provides information on an assay replicate you generated.

This element has the following attributes:

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

Context:

/Basic bioassay protocol/

Assay replicate document

Provides a link to the Quantitative response assay document you generated. Shift-click the link to open the document.

This element has the following attributes:

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

Context:

/Basic bioassay protocol/Assay replicate/

Assay suitability tests

Add the Assay suitability tests you require.

The results of Assay suitability tests affect the whole assay document rather than just individual Standard-vs-Test sample comparisons.

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/

Assay template

Specify a template you need to generate Quantitative response assay documents.

Tip: Add a Valid for replicate element to restrict use of the template. This element allows you to enter an assay replicate number. The template is then only used to generate this particular replicate.

This element has the following attributes:

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

Context:

/Basic bioassay protocol/Templates/Assay templates/

Assay templates

Specify the templates you need to generate Quantitative response assay documents.

This element has the following attributes:

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

Context:

/Basic bioassay protocol/Templates/

Assigned/assumed potency

Enter the assigned potency (for a Standard sample) or assumed potency (for a Test sample).

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/Assigned/assumed potency (summary)/

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

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

/Basic bioassay protocol/choice/Mode: Assay element/Standard sample/choice/Absolute potency: Defined by stock solution/

/Basic bioassay protocol/choice/Mode: Assay element/Test sample/choice/Absolute potency: Defined by stock solution/

/Basic bioassay protocol/choice/Mode: Assay element/Control sample/choice/Absolute potency: Defined by stock solution/

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

/Quantitative response assay/Setup/Preparation schemes/Preparation scheme/choice/Absolute potency: Defined by stock solution/

Assigned/assumed potency (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/

Assigned/assumed potency units

Enter the unit for assigned/assumed potency to be used in reporting.

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/Assigned/assumed potency (summary)/

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

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

/Basic bioassay protocol/choice/Mode: Assay element/Standard sample/choice/Absolute potency: Defined by stock solution/

/Basic bioassay protocol/choice/Mode: Assay element/Test sample/choice/Absolute potency: Defined by stock solution/

/Basic bioassay protocol/choice/Mode: Assay element/Control sample/choice/Absolute potency: Defined by stock solution/

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

/Quantitative response assay/Setup/Preparation schemes/Preparation scheme/choice/Absolute potency: Defined by stock solution/

Asymmetry parameter (G) (nonlinear models)

This parameter is used for the following model:

  • 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/

Asymmetry parameter (G) (nonlinear models)

Use this test for the following model:

  • 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/

Asymptote fixed by control line

Specifies the Control line to be used to fix the asymptote. Select a Control line from the Value drop-down list.

Note: The mean of the response values of the Control line is used as value of the fixed asymptote.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Analytical model/choice/Model: 3-parameter logistic fit with fixed lower asymptote/choice/

/Quantitative response assay/Analysis/Analytical model/choice/Model: 3-parameter logistic fit with fixed upper asymptote/choice/

Asymptote fixed by value

Enter the number to be used as value of the fixed asymptote.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Analytical model/choice/Model: 3-parameter logistic fit with fixed lower asymptote/choice/

/Quantitative response assay/Analysis/Analytical model/choice/Model: 3-parameter logistic fit with fixed upper asymptote/choice/

Author

Automatically inserts the user name of the current user when the Author element is created. You can enter a different name.

This element has the following attributes:

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

B parameter (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/

B parameter (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/

Base

Enter a number to specify the Base of this sequence. The number you enter must be a positive 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/

Basic bioassay protocol

The Basic bioassay protocol document type allows you to calculate reportable potency values from assay replicates (independent biological assays).

This element has the following attributes:

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

Context:

Top level

Block-based by Control line

Calculates an adjustment value for each block factor by subtracting the mean of all Control line responses from the mean of the Control line responses assigned to the respective block factor. The adjustment value is applied to all observations assigned to the block factor.

Tip: If you require a different adjustment type, 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/Adjustment/choice/

Block-based by Control line

Calculates the mean of all Control line responses of the respective block factor and divides all response values of the block factor by the calculated value.

Tip: If you require a different normalization type, 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/Normalization/choice/

Block factor

Select the dataset column you want to use to define this block factor. Select a Text or a Position factor column.

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Response data processing/choice/Adjustment/choice/Block-based by Control line/

/Quantitative response assay/Analysis/Response data processing/choice/Normalization/choice/Block-based by Control line/

by Control line

Select an option from the 'Control line' drop-down list below to specify the Control line to be used for calculating the adjustment value. By default, the adjustment you select is applied to every response value.

Tip: If you require a different adjustment type, 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/Adjustment/choice/

by Control line

Select an option from the 'Control line' drop-down list below to specify the Control line to be used for calculating the normalization value. By default, the normalization you select is applied to every response value.

Tip: If you require a different normalization type, 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/Normalization/choice/

by Fixed value

Enter a number to specify the Fixed value to be subtracted from your response values. By default, the number you enter is subtracted from every response value.

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

This element has the following attributes:

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

Context:

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

by Fixed value

Enter a number to specify the Fixed value by which your response values are to be divided. By default, every response value is divided by the number you enter.

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

This element has the following attributes:

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

Context:

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