Learn how to define test strategies in Equivalence margin development
documents.
Before you begin
We recommend becoming familiar with the test strategies concept of PLA 3.0 before beginning. For details, see the
Test strategies topic.
About this task
When defining test strategies, you define how PLA 3.0 applies equivalence margins
and other parameters during suitability testing. PLA 3.0 evaluates each assay according
to the strategy and creates respective visualizations. Development and verification
assays are handled separately.
Procedure
In the Content editor of your Equivalence margin development document, go to Test strategies > Strategy.
Enter a name for your strategy.
Select and set up the tests you want to include in your strategy.
If required, add additional strategies and repeat steps 2 and 3 until you have
defined all strategies.
Save the document.
Example
The following image from the 'Equivalence margin
development and verification' sample document shows two test strategies. One
strategy for point estimate tests, the other strategy for equivalence and ANOVA term tests:Figure 1. Sample setup of two test strategies for equivalence margin
development
