M–R

Find reference information on document elements of the Dichotomous Assay Package, letters M to R.

Maximal group number

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

This element has the following attributes:

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

Context:

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

Meaning

Enter text to specify the signatures this document requires.

Tip: You can enter multiline text.
Note: If you enter a Meaning, the test only accepts and counts signatures that match this Meaning.

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/Signature state/

Memo column (factor)

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

Model: Logit

Uses the Logit regression model to estimate relative potency.

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

The model is defined by the following equation:

log b P( Dose ) 1 - P( Dose ) = m log b ( Dose ) + n

This element has the following attributes:

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

Context:

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

Model: Probit

Uses the Probit regression model to estimate relative potency.

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

The model is defined by the following equation:

P( Dose ) = Φ m log b ( Dose ) + n

This element has the following attributes:

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

Context:

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

Name

Enter a name for the Control sample.

Examples:

'Assay control', 'Control 3', 'Ctr'

Note: This name is also displayed in the Observation group ID column of the Observations editor. The name is used to report test results, data values, and estimates related to this Control sample.
Tip: We recommend to use assay element names that are unique within the assay document. But this is not required. Assay elements are internally identified by their unique Observation group ID.

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/Assay Elements/Control Sample/

Name

Enter a name for this column.

This element has the following attributes:

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

Context:

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

Name

Enter a name for this document.

Note: Documents are usually identified by name. We therefore recommend to use unique document names. But this is not required.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/

Name

Enter a name for the Preparation scheme.

Note: Preparation scheme names are required to be unique within assays.

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/

Name

Enter a name for the Test sample.

Examples:

'Preparation 1', 'Unknown 3', 'Test 2'

Note: This name is also displayed in the Observation group ID column of the Observations editor. The name is used to report test results, data values, and estimates related to this Test sample.
Tip: We recommend to use assay element names that are unique within the assay document. But this is not required. Assay elements are internally identified by their unique Observation group ID.

This element has the following attributes:

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

Context:

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

Name

Enter a name for the Standard sample.

Examples:

'Standard', 'Std', 'Reference standard'

Note: This name is also displayed in the Observation group ID column of the Observations editor. The name is used to report test results, data values, and estimates related to this Standard sample.
Tip: We recommend to use assay element names that are unique within the assay document. But this is not required. Assay elements are internally identified by their unique Observation group ID.

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/Assay Elements/Standard Sample/

Number of signatures

Enter a number to specify how many signatures this document requires.

This element has the following attributes:

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

Context:

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

Number of steps

Enter a number to specify how many dose steps this sequence requires.

This element has the following attributes:

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

Context:

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

Observation data

This section allows you to modify the data table that displays observation data in the Observations editor.

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 group (factor)

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

Note: The Maximal group number limits the number of observation groups (assay elements) for which the Observations editor can display data. If your assay document has more assay elements, you require more observation groups and must change the Maximal group number accordingly.

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/

Observation group ID

Displays the Observation group ID.

Note: Observation group IDs are natural numbers (zero not included).

When you create an assay element, a unique Observation group ID is automatically assigned. Since Observation group IDs are required to be unique within assays, we do not recommend to change them manually.

Important: If you manually change the Observation group ID in the definition of an assay element, this does not change the Observation group IDs of observations that may be assigned to this assay element.
Tip: The Observation group ID is displayed in square brackets in the Observation group column of the Observations editor.

This element has the following attributes:

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

Context:

/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/

Observation source

Select how you want to obtain observation data. The following options are available from the drop-down list:

  • User input: Enter data manually.
  • Aggregation: Specify document references to aggregate data from documents.
  • Import: Not supported.

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/Observation Data/

Operator

This section allows you to provide information on an operator. Expand the node to add or view information.

To add an Operator name or reference: Select the required option from the drop-down list, and enter the name or reference.

To assign a role to the operator: Add the Role element from the Creatable elements pane, and enter the required role.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Documentation/

Operator name

Enter the name of the operator.

Tip: You can enter a reference to an operator document instead. Select the Operator reference option from the drop-down list.

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/Operator/choice/

Operator reference

Select an operator document.

Tip: You can enter an operator name instead. Select the Operator name option from the drop-down list.

This element has the following attributes:

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

Context:

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

p

Enter the significance level (alpha) for the p-value of the test. A common value is 0.05.

Note: The test evaluation is based on comparing p-values, which are calculated from a test statistic, to the significance level you enter. This is equivalent to comparing test statistics to critical values.

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/Chi-Square-Test / Z-Test (Hypothesis Test)/choice/

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

Potency estimation confidence level

Select the confidence level of the potency confidence interval. A common value is 95%.

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/

Predilution factor

Enter a single predilution factor. The calculation uses the reciprocal value (1 / Predilution factor).

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Setup/Preparation Schemes/Preparation Scheme/Predilution factors/

Predilution factors

Select this option if you want to provide predilution factors directly. To add a Predilution factor: Double-click Predilution factor in the Creatable elements pane. When the assays are analyzed, a final predilution factor is calculated by multiplying all predilution factors entered here.

Note: Predilution factors are considered after relative potency is calculated. They do not enter the calculation for model fit.

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/

Preparation scheme

Assign a Preparation scheme to this assay element. Preparation schemes define dilution sequences, absolute potencies, and predilution settings of assay elements.

This element has the following attributes:

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

Context:

/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/

Preparation scheme

This section allows you to define a Preparation scheme. Preparation schemes contain settings on dose sequence, absolute potency, and predilution factors. Expand the node to add or view information.

Note: In every assay element, you must reference exactly one Preparation scheme.
Tip: You can reference any Preparation scheme from more than one assay element.

This element has the following attributes:

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

Context:

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

Preparation schemes

This section allows you to set up multiple Preparation schemes to define doses and dimensions of your treatments. Expand the node to add or view information.

Note: All assay elements are associated with the first Preparation scheme by default. Add additional Preparation schemes as you require.
Tip: Use the context menu or Creatable elements pane to add Preparation schemes.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Setup/

Probability: Data plot

Change settings to adjust display of data plots for the probability fit.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Settings/Graphics/

Probability: Full model

Change settings to adjust display of full models for the probability fit.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Settings/Graphics/

Probability: Restricted model

Change settings to adjust display of restricted models for the probability fit.

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Settings/Graphics/

Property key

Select a Property key to identify the data to be aggregated.

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/

Property key

Select the key of the document property you want to use. Only documents in which an element has this property key will be considered for the import.

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/Document property filter/

Property key

Select the key of the document property you want to use. The key specifies which data element of the linked document is to be imported into this document.

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/Document property import/

Property key

Select the key of the section property you want to use. Only documents in which an element has this property key will be considered for the import.

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/

Property key

Select the key of the section property you want to use. The key specifies which data element of the linked document is to be imported into this document.

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 import/

Property scope

Select a Property scope from the drop-down list.

Note: The scope only applies to document aggregation.

The following options are available to specify the source of the aggregated property:

  • Document
  • Section

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/

Reagent

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

This element has the following attributes:

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

Context:

/Dichotomous Assay (Quantal Response Assay)/Documentation/

Reagent batch/lot number

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

This element has the following attributes:

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

Context:

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

Reagent class

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

This element has the following attributes:

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

Context:

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

Reagent description

Enter a description of the reagent.

Tip: You can enter multiline text.

This element has the following attributes:

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

Context:

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

Reagent identification

Enter information to identify the reagent.

This element has the following attributes:

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

Context:

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

Reagent name

Enter a name for the reagent.

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

This element has the following attributes:

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

Context:

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

Reagent reference

Select a reagent document.

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

This element has the following attributes:

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

Context:

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

Reagent sub-batch/sub-lot number

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

This element has the following attributes:

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

Context:

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

Reagent variant

Enter the variant of the reagent.

This element has the following attributes:

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

Context:

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

Replicate count

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

This element has the following attributes:

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

Context:

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

Response (affected)

Displays the number of affected responses.

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/

Response (tested)

Displays the total number of tested responses.

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/

Role

Enter the role of the operator.

This element has the following attributes:

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

Context:

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

Rounding

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

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

The following options are available:

  • No rounding
  • x decimal places (where x is an integer from 0 to 10)
Note: The rounding method 'half away from zero' is used.
Note: You may need this feature to follow protocol procedures or company regulations. We do not recommend to use rounding for test evaluation.

This element has the following attributes:

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

Context:

/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/

Row order

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

This element has the following attributes:

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

Context:

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