Test: Potency confidence interval (%)

Add one or several tests for the percentual potency confidence interval to your assay. To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important: Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the lower confidence limit of the percentual 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 percentual potency has to be less than or equal to the Upper margin.

Supported models

Linear parallel-line, 4-parameter logistic, 5-parameter logistic, 3-parameter logistic with fixed lower asymptote, 3-parameter logistic with fixed upper asymptote, Slope ratio

Assay elements

Test, Control

This element has the following attributes:

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

Context:

/Quantitative response assay/Analysis/Suitability tests/Assay suitability tests/alternatives/

/Quantitative response assay/Analysis/Suitability tests/Sample suitability tests/alternatives/

/Test system definition (Quantitative response assay)/Suitability tests/Assay suitability tests/alternatives/

/Test system definition (Quantitative response assay)/Suitability tests/Sample suitability tests/alternatives/