Development of Generic Equivalence Margins for Early-Stage Implementation of Equivalence Testing for Potency Assays.

Relative potency assays for biological therapeutics require statistical evaluation to demonstrate similarity between the dose-response curves of a reference standard and the test samples. We developed an equivalence testing approach that can be utilized for the complete potency assay life cycle, from early development until commercialization. This approach was based on the use of generic equivalence margins to enable equivalence testing at the beginning of assay development, when the body of assay-specific data is still very limited.