A–D

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.

This element has the following attributes:

Select this option if you want to provide the absolute potency directly. Expand the node to add or view information.

This element has the following attributes:

This option does not define an absolute dose for the assay element.

This element has the following attributes:

This section provides additional settings for assay calculation.

This element has the following attributes:

Select the

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.

This element has the following attributes:

Enter the amount of the substance.

This element has the following attributes:

Expand the node to add or view information.

This element has the following attributes:

Enter the unit for Amount to be used in reporting.

This element has the following attributes:

This section allows you to specify the Analytical model (regression) and Suitability tests (statistical tests) to be used in calculations.

Expand the node to add or view information.

This element has the following attributes:

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

This element has the following attributes:

This section allows you to define all assay elements. Expand the node to add or view information.

Dichotomous assay documents contain three types of assay elements: The Standard sample, Test samples, and Control samples. Standard, Test, and Control samples are diluted samples.

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.

This element has the following attributes:

Enter text that describes the purpose of this assay. Provide the analyte (target of the analysis), for example, and its unique identification.

This element has the following attributes:

Add the Assay suitability tests you require.

This element has the following attributes:

Enter the Assigned potency (for a Standard sample) or Assumed potency (for a Test sample).

This element has the following attributes:

Expand the node to add or view information.

This element has the following attributes:

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

This element has the following attributes:

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:

Enter a number to specify the Base of this sequence.

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

This element has the following attributes:

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

This element has the following attributes:

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

This element has the following attributes:

Add one or several Chi-square tests/ Z-tests to your assay. The following Types are available:

Chi-square tests

• Significance of non-parallelism
• Significance of non-linearity (lack of fit)
• Significance of non-linearity (lack of fit) for a single assay element
• Significance of regression

Z-tests

• Significance of the square coefficient
• Significance of the square coefficient for a single assay element

This element has the following attributes:

Displays the Column key.

This element has the following attributes:

Enter a key for this column.

This element has the following attributes:

Displays the Column key.

This element has the following attributes:

Enter a key for this column.

This element has the following attributes:

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

This element has the following attributes:

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:

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

This element has the following attributes:

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:

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

This element has the following attributes:

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.

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:

This section provides information on imported data. Expand the node to add or view information.

This element has the following attributes:

Automatically inserts the current date and time when the Date element is created. You can enter a different date and time.

This element has the following attributes:

Automatically inserts the current date and time when the document is created. You can enter a different date and time.

This element has the following attributes:

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

This element has the following attributes:

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

This element has the following attributes:

Allows you to define a sequence by specifying each Dose value individually. Select a different sequence type from the drop-down list if you require.

This element has the following attributes:

Enter a number to specify the difference between the dose values of this sequence.

The dose value for step number 'j' of a linear sequence is given by:

This element has the following attributes:

Dichotomous assays are dilution assays based on a dichotomous response. Unlike quantitative response, dichotomous response is measured on a discrete scale.

Navigate through the properties to select or enter settings you require for this Dichotomous assay:

1. Expand the node to add or view information. The second level of the document structure displays the Name and Date of the document. It also provides access to the Documentation, Setup, and Analysis sections.

2. Double-click the Identification element in the Creatable elements pane to add it to the document.

3. Double-click the Comment or Settings element in the Creatable elements pane to add a Comment or Settings section to the document.

This element has the following attributes:

Enter a number to set the Dilution factor for an individual step in the dilution sequence. The dose of this step is equal to the dose of the previous step divided by the dilution factor.

This element has the following attributes:

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

This element has the following attributes:

Select the color to be used to display data of this assay element in graphs and tables. When you create an assay element, a color is automatically assigned. Select the color field to display controls that allow you to change the color.

This element has the following attributes:

Select the 'yes' option from the drop-down list to add horizontal grid lines to your plots.

This element has the following attributes:

Select the 'yes' option from the drop-down list to add a legend to your plots.

This element has the following attributes:

Select the 'yes' option from the drop-down list to add vertical grid lines to your plots.

This element has the following attributes:

Select a Document mode from the drop-down list to require referenced documents match this mode.

This element has the following attributes:

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

This element has the following attributes:

Define the document property you want to import.

This element has the following attributes:

Add the Document suitability tests you require.

This element has the following attributes:

Select the document type of the documents to be referenced.

This element has the following attributes:

This section allows you to provide information on operators, analyte, reagents, and equipment. Expand the node to add or view information.

This element has the following attributes:

Enter a number to set a Dose value for the Defined sequence.

This element has the following attributes: