C

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:

Context:

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

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:

Context:

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

Select the 'yes' option from the drop-down list to have the mean of the potency estimates reported.

This element has the following attributes:

Context:

/Quantitative response assay/Analysis/Analytical model/

Selects the method to be used to calculate the Coefficient of determination, which is also known as R² value. The following options are available from the drop-down list:

• Default method: Uses the intercept-free model in assays based on linear regression models, and the mean-adjusted model in assays based on nonlinear regression models.
  Note: Assays based on the restricted regression model of the Slope ratio are an exception where also the mean-adjusted model is used by default.
• Mean-adjusted model: Calculates the Coefficient of determination based on the following equation:
  $$R^2=1-\genfrac{}{}{0.1ex}{}{{\displaystyle \sum _i}{({\widehat{y}}_i-y_i)}^2}{{\displaystyle \sum _i}{(y_i-\overline{y})}^2}$$

  Where ȳ is the average response, y_i is the i-th response and ŷ_i is the i-th reponse predicted by the fitted model.

• Intercept-free model: Calculates the Coefficient of determination based on the following equation:
  $$R^2=1-\genfrac{}{}{0.1ex}{}{{\displaystyle \sum _i}{({\widehat{y}}_i-y_i)}^2}{{\displaystyle \sum _i}{y}_i^2}$$

  Where y_i is the i-th response and ŷ_i is the i-th reponse predicted by the fitted model.

This element has the following attributes:

Context:

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

Specify which sections of referenced documents you require to develop or verify margins.

This element has the following attributes:

Context:

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

Expand the node to add or view information.

This element has the following attributes:

Context:

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

Marks dataset rows as development assays, verification assays, or excluded from calculation. Rows marked as development assays are used to derive margins. Rows marked as verification assays are used to test derived margins.

This element has the following attributes:

Context:

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

Define a column that allows you to associate each observation with a logical/ Boolean value.

This element has the following attributes:

Context:

/Quantitative response assay/Setup/Observation data/choice/

Define a column that allows you to associate each observation with a date.

This element has the following attributes:

Context:

/Quantitative response assay/Setup/Observation data/choice/

Define a column that allows you to associate each observation with a date and time.

This element has the following attributes:

Context:

/Quantitative response assay/Setup/Observation data/choice/

Expand the node to add or view information.

This element has the following attributes:

Context:

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

Marks dataset rows to be excluded from calculating margins.

This element has the following attributes:

Context:

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

Provides a column to flag technical outliers in the data table.

This element has the following attributes:

Context:

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

Define a column that allows you to associate each observation with a value of double-precision floating-point number format.

This element has the following attributes:

Context:

/Quantitative response assay/Setup/Observation data/choice/

Define a column that allows you to associate each observation with a value of integer number format.

This element has the following attributes:

Context:

/Quantitative response assay/Setup/Observation data/choice/

Displays the Column key. The key is required to define a sort order based on this column.

This element has the following attributes:

Context:

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

Enter a key for this column. The key is required to define a sort order based on this column.

This element has the following attributes:

Context:

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

Currently, no information available.

This element has the following attributes:

Context:

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

Displays the Column key. The key is required to define a sort order based on this column.

This element has the following attributes:

/Basic bioassay protocol/Reportable values/Document reference/

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

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

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

Enter a key for this column. The key is required to define a sort order based on this column.

This element has the following attributes:

Context:

Define a column that allows you to associate each observation with a multiline text.

This element has the following attributes:

Context:

/Quantitative response assay/Setup/Observation data/choice/

Expand the node to add or view information.

This element has the following attributes:

Context:

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

Links individual observations (measurements) to their assay elements. All observations of a group belong to the same assay element.

This element has the following attributes:

Context:

/Quantitative response assay/Setup/Observation data/

Lists for each observation the microplate column in which the observation occurred.

This element has the following attributes:

Context:

/Quantitative response assay/Setup/Observation data/

Expand the node to add or view information.

This element has the following attributes:

Context:

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

Displays the observed response value.

This element has the following attributes:

Context:

/Quantitative response assay/Setup/Observation data/

Marks dataset rows for positive or negative verification. Set to 'Passed' if you expect the assay of the row will be accepted. Set to 'Failed' if you expect the assay of the row will be rejected.

This element has the following attributes:

Context:

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

Expand the node to add or view information.

This element has the following attributes:

Context:

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

Expand the node to add or view information.

This element has the following attributes:

Context:

/Quantitative response assay/Setup/Observation data/

Displays the sequence step number and the dose value.

This element has the following attributes:

Context:

/Quantitative response assay/Setup/Observation data/

Displays flags to mark technical outliers.

This element has the following attributes:

Context:

/Quantitative response assay/Setup/Observation data/

Define a column that allows you to associate each observation with a single-line text.

This element has the following attributes:

Context:

/Quantitative response assay/Setup/Observation data/choice/

Define a column that allows you to associate each observation with a time.

This element has the following attributes:

Context:

/Quantitative response assay/Setup/Observation data/choice/

Define a combination calculation based on the specified configuration.

This element has the following attributes:

Context:

/Basic bioassay protocol/

Define a combination calculation based on the specified configuration.

This element has the following attributes:

Context:

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

Specify the templates you need to generate Combination of assay results documents.

This element has the following attributes:

Context:

/Basic bioassay protocol/Templates/

Provides a link to the Combination of assay results document you generated. Shift-click the link to open the document.

This element has the following attributes:

Context:

/Basic bioassay protocol/choice/Mode: Assay element/Test sample/Combination calculation (sample only)/

/Basic bioassay protocol/Combination calculation/

The Combination of assay results document type allows you to perform combination calculations for independent assay runs, thus obtaining reportable values for the potency.

We support the following combination calculation methods:

• Unweighted calculation
• Weighted calculation (by homogeneity)
• Homogeneously weighted calculation
• Heterogeneously weighted calculation according to European Pharmacopoeia Chapter 5.3, US Pharmacopeia <111> (semi-weighted), and US Pharmacopeia <1034>

This element has the following attributes:

Context:

Top level

Select the method according to which the combination calculation should be performed.

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

• Unweighted: CI based on inter-assay variation
• Weighted: CI based on intra-assay variation
• Weighted: CI based on inter- and intra-assay variation

This element has the following attributes:

Context:

/Combination of independent assay results/Analysis/choice/

The system decides which method to use, based on the result of the Chi-square test on homogeneity.

This element has the following attributes:

Context:

/Combination of independent assay results/Analysis/choice/

Enter a comment, or add a reference to a comment document.

This element has the following attributes:

/Basic bioassay protocol/

/Combination of independent assay results/

/Equivalence margin development (Quantitative response assays)/

/Quantitative response assay/

/Test system definition (Quantitative response assay)/

We support weighting types according to the following compendial guidances:

• EP4th-9th: The weighting is done as described in the European Pharmacopoeia 4th to 9th edition.
• EP10th: The weighting is done as described in the European Pharmacopoeia 10th edition.
• USP<111>: The heterogeneous weighting is done as described in chapter 111 of the US Pharmacopeia. This type is also referred to as semi-weighting.
• USP<1034>: The heterogeneous weighting is done as described in the (new) chapter 1034 of the US Pharmacopeia.

This element has the following attributes:

Context:

/Combination of independent assay results/Analysis/

Enter the unit used for the concentrations of sequences. This is the concentration unit of your stock solution. The unit you enter here applies to all concentration steps. This value specifies the working concentration to be used by the calculation for this step of the concentration sequence.

This element has the following attributes:

Context:

/Quantitative response assay/Setup/Observation data/Column: Sequence step/

Make the execution of this test dependent on the results of another test.

This element has the following attributes:

Context:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Select the Confidence level for which margins are to be calculated. A common value is 90%. The value you select applies to margin development with tests that use confidence intervals.

A higher confidence level produces broader confidence intervals, which results in a greater equivalence range (distance between equivalence margins).

This element has the following attributes:

Context:

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

Select the Confidence level of the test. A common value is 95%.

This element has the following attributes:

Context:

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

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

Select the Confidence level of the test. A common value is 95%.

This element has the following attributes:

Context:

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

Currently, no information available.

This element has the following attributes:

Context:

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

Configure the document reference. Expand the node to add or view information.

Add elements to change the document selection and generation process. You can restrict the selected document to a particular folder, for example.

The following child elements are available:

• Update mode
• Template key
• Folder key
• Allow subfolders
• Generator key
• Document mode

This element has the following attributes:

/Combination of independent assay results/Documentation/Operator/choice/Operator reference/

/Quantitative response assay/Documentation/Operator/choice/Operator reference/

Set up the details of the linked document and the data you want to import.

This element has the following attributes:

/Basic bioassay protocol/Comment/Linked document/

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

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

Context:

Specify the template you need to generate Combination of assay results documents.

This element has the following attributes:

Context:

/Basic bioassay protocol/Templates/Combination calculation templates/

Enter a name for the configuration.

This element has the following attributes:

Context:

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

Select a configuration for this combination calculation from the drop-down list.

This element has the following attributes:

Context:

/Basic bioassay protocol/choice/Mode: Assay element/Test sample/Combination calculation (sample only)/

/Basic bioassay protocol/Combination calculation/

Select an option from the drop-down list. Use the Maximum range option to have the configuration optimizer find good configurations with preference to large ranges. Otherwise, use the Best ranges option.

This element has the following attributes:

Context:

/Quantitative response assay/Analysis/Data selection schemes/

Select the Control line to be used for calculating the adjustment value.

This element has the following attributes:

Context:

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

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

This section allows you to provide information on a Control line. Control lines refine the characteristics of assays. Unlike Control samples, Control lines do not have a dilution or dose.

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

Expand the node to add or view information.

This element has the following attributes:

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

/Quantitative response assay/Setup/Assay elements/

Select the Control line to be used for calculating the normalization factor.

This element has the following attributes:

Context:

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

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

This section allows you to provide information on a Control sample. The potency of Control samples is calculated in the same way as the potency of Test samples. Control samples are not included in Combination of assay results calculations.

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

Expand the node to add or view information.

This element has the following attributes:

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

/Quantitative response assay/Setup/Assay elements/

Enter a decimal number to be used as covariance of the upper asymptote and the lower asymptote of the Standard sample. Simulation uses it for testing sampled parameter configurations. If you do not enter a value, 0 is used as default.

This element has the following attributes:

Context:

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

Enter a decimal number to be used as covariance of the upper asymptote and the lower asymptote of the Test/ Control sample. Simulation uses it for testing sampled parameter configurations. If you do not enter a value, 0 is used as default.

This element has the following attributes:

Context:

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

Define the covariances for the simulation of model parameters. For each parameter, simulation samples a value from the uniform distribution with given limits. If no covariances are defined, 0 is used as default.

This element has the following attributes:

Context:

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

Currently, no information available.

This element has the following attributes:

Context:

/Test system definition (Quantitative response assay)/