S–Z

Find reference information on document elements of the Dichotomous Assay Package, letters S to Z.

Sample suitability tests

Add the Sample suitability tests you require.

Important: The results of Sample suitability tests just affect the individual Standard-vs-Test sample comparison for which they are set rather than the whole assay document.
Note: With simultaneous regression (formerly called multiplex assay), there is no difference in how Assay suitability tests and Sample suitability tests are evaluated.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/

Scope of the test

Select the assay elements you want to include in the test. 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.
Note: The test type also influences which assay elements are included in a test. 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. Please consult the help pages on particular tests for additional information.
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).

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/choice/Chi-Square-Test / Z-Test (Hypothesis Test)/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/choice/Test: Relative Potency Value/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/choice/Test: Relative-potency confidence interval/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/choice/Test: Relative-potency range (%)/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/choice/Test: Weight (W)/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/choice/Test: EC50 value/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Sample Suitability Tests/choice/Chi-Square-Test / Z-Test (Hypothesis Test)/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Sample Suitability Tests/choice/Test: Relative Potency Value/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Sample Suitability Tests/choice/Test: Relative-potency confidence interval/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Sample Suitability Tests/choice/Test: Relative-potency range (%)/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Sample Suitability Tests/choice/Test: Weight (W)/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Sample Suitability Tests/choice/Test: EC50 value/

Scope of the test

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

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Document Suitability Tests/choice/Signature state/

Section key

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

Note: The key only applies to document aggregation.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/Column: Observation Group/

Section key

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Comment/Linked Document/Config/Section property filter/

Section property filter

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Comment/Linked Document/Config/

Section property import

Define the section property you want to import.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Comment/Linked Document/Config/

Sequence step

Displays the sequence step number and the dose value.

Note: The total number of steps and replicates of an assay element is defined in the preparation scheme referenced by this assay element.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/

Settings

This section allows you to adjust various settings.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/

Setup

This section allows you to set up this assay. Expand the node to add or view information.

This section provides the following features:

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/

Severity level of the test

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

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

Note: Each assay also provides a summary of test results, which is called 'Overall test result'.
  • Reject: If the test fails, no potencies are reported. For reporting the Overall test result, the test is considered 'Rejected'.
  • If the test fails, potencies are reported. For reporting the Overall test result, the test is considered 'Failed'.
  • Information: If the test fails, potencies are reported. For reporting the Overall test result, the test is considered 'Passed' (info available).

The following table explains how the Severity levels of failed tests influence the Overall test result:

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

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Document Suitability Tests/choice/Signature state/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Document Suitability Tests/choice/Test on user variable/

Signature state

Add one or several tests for the signature state.

Note: You must select a Scope and a Severity level for the test from the drop-down lists.
Tip: Add Meaning and Number of signatures elements to the test to specify the signature and the number of signatures required.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Document Suitability Tests/choice/

Simultaneous regression

Specifies how the assay is to be evaluated. Set Simultaneous regression to 'yes' if all samples are to be regarded as one single dataset and approximated together. Set Simultaneous regression to 'no' if the samples are to be regarded as a collection of Standard-vs-Test comparisons with each pair approximated separately.

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Analysis/Analytical Model/

Solvent (summary)

Expand the node to add or view information.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Setup/Preparation Schemes/Preparation Scheme/choice/Absolute Potency: defined by Raw Material/

Solvent volume

Enter the volume of the solvent.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Setup/Preparation Schemes/Preparation Scheme/choice/Absolute Potency: defined by Raw Material/Solvent (Summary)/

Solvent volume units

Enter the unit for Solvent volume.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Setup/Preparation Schemes/Preparation Scheme/choice/Absolute Potency: defined by Raw Material/Solvent (Summary)/

Standard sample

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

Expand the node to add or view information.

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/

Stepwise dilution sequence

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

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Setup/Preparation Schemes/Preparation Scheme/choice/

Substance batch/lot number

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Documentation/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/

Substance class

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Documentation/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/

Substance description

Enter a description of the substance.

Tip: You can enter multiline text.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Documentation/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/

Substance identification

Enter information to identify the substance.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Documentation/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/

Substance name

Enter a name for the substance.

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Documentation/choice/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/choice/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/choice/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/choice/

Substance reference

Select a substance document.

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Documentation/choice/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/choice/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/choice/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/choice/

Substance sub-batch/sub-lot number

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Documentation/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/

Substance variant

Enter the variant of the substance.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Documentation/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/

Suitability tests

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

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Analysis/

Technical-outlier flag (factor)

Displays flags to mark technical outliers.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/

Template key

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Comment/Linked Document/Config/

Term

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

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Comment/Linked Document/Config/Document property filter/

Test: EC50 value

Add one or several tests for the EC50 value to your assay.

Note: To pass the test, the estimated EC50 value has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.
Tip: Select the Assay suitability or Sample suitability section prior to adding tests. To add an assay suitability test, select the Assay suitability tests element or one of its children prior to adding the test from the Context list. To add a sample suitability test, select the Sample suitability tests element or one of its children.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/choice/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Sample Suitability Tests/choice/

Test on user variable

Add one or several tests for a user variable.

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Document Suitability Tests/choice/

Test: Relative-potency confidence interval

Add one or several tests for the relative-potency confidence interval to your assay.

Note: To pass the test, the lower confidence limit of the relative potency has to be greater than or equal to the Lower margin set in the test definition, and the upper confidence limit of the relative potency has to be less than or equal to the Upper margin.
Tip: Select the Assay suitability or Sample suitability section prior to adding tests. To add an assay suitability test, select the Assay suitability tests element or one of its children prior to adding the test from the Context list. To add a sample suitability test, select the Sample suitability tests element or one of its children.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/choice/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Sample Suitability Tests/choice/

Test: Relative-potency range (%)

Add one or several tests for the relative-potency range to your assay.

Note: To pass the test, the percentual relative-potency range has to be less than or equal to the Upper margin set in the test definition.
Tip: Select the Assay suitability or Sample suitability section prior to adding tests. To add an assay suitability test, select the Assay suitability tests element or one of its children prior to adding the test from the Context list. To add a sample suitability test, select the Sample suitability tests element or one of its children.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/choice/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Sample Suitability Tests/choice/

Test: Relative-potency value

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

Note: To pass the test, the relative-potency value has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.
Tip: Select the Assay suitability or Sample suitability section prior to adding tests. To add an assay suitability test, select the Assay suitability tests element or one of its children prior to adding the test from the Context list. To add a sample suitability test, select the Sample suitability tests element or one of its children.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/choice/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Sample Suitability Tests/choice/

Test sample (unknown)

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

Expand the node to add or view information.

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

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/

Test: Weight (W)

Add one or several tests for the weight.

Note: To pass the test, the potency weight has to be greater than or equal to the Lower margin set in the test definition.
Note: The weight is defined in the European Pharmacopoeia 6.0, Chapter 5.3, Equation 6.2.1.-1.
Tip: Select the Assay suitability or Sample suitability section prior to adding tests. To add an assay suitability test, select the Assay suitability tests element or one of its children prior to adding the test from the Context list. To add a sample suitability test, select the Sample suitability tests element or one of its children.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/choice/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Sample Suitability Tests/choice/

Text

Enter the subject of this comment.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Comment/

Text

Enter your comment.

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Comment/

Text column (factor)

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/choice/

Theoretical variance

Enter a different value for Theoretical variance if you require.

Note: This setting affects tests based on ANOVA.

The default value is '1'.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Analysis/Analytical Model/Advanced Settings/

Time column (factor)

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/choice/

Type of Chi-square test / Z-test

Select the Chi-square or Z-test Type you want to use from the drop-down list. Please consult the help page on the Chi-square test/ Z-test (hypothesis test) for additional information.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/choice/Chi-Square-Test / Z-Test (Hypothesis Test)/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Sample Suitability Tests/choice/Chi-Square-Test / Z-Test (Hypothesis Test)/

Update mode

Select how you want to update data provided by the referenced document. The following options are available from the drop-down list:

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Documentation/choice/Substance Reference/Config/

/Dichotomous Assay (Quantal Response Assay)/Documentation/Reagent/choice/Reagent Reference/Config/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/choice/Substance Reference/Config/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/choice/Substance Reference/Config/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/choice/Substance Reference/Config/

Upper margin

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

Note: Additional information is provided on the help page of the test.
Tip: Set up an Equivalence margin document in PLA if you have historical data to determine the margins for your tests.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/choice/Test: Relative-potency range (%)/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Sample Suitability Tests/choice/Test: Relative-potency range (%)/

Upper margin

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

Note: Additional information is provided on the help page of the test.
Tip: Set up an Equivalence margin document in PLA if you have historical data to determine the margins for your tests.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/choice/Test: Relative Potency Value/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/choice/Test: Relative-potency confidence interval/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/choice/Test: EC50 value/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Sample Suitability Tests/choice/Test: Relative Potency Value/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Sample Suitability Tests/choice/Test: Relative-potency confidence interval/

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Sample Suitability Tests/choice/Test: EC50 value/

User instructions

Enter text to be displayed in the User instructions section of the dashboard. User instructions are intended for template designers. You can enter multiline text and add Markdown tagging to format User instructions.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Documentation/

User variable

Define user variables for custom reports/ custom component packages. They have no functionality in standard reports/ standard component packages.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Documentation/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/

Value

Enter the value of the user variable for the test.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Document Suitability Tests/choice/Test on user variable/

Value

Enter the value you want to use in custom reports/ custom component packages.

Tip: You can enter multiline text.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Documentation/User Variable/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/User Variable/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/User Variable/

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/User Variable/