The development of equivalence margins for use according to the US Pharmacopeia is a challenging task. With PLA 3.0, you are able to aggregate your reference data and calculate candidate equivalence margins.
First, choose acceptable historic bioassays. PLA can calculate margins from any number of assays for a quick start. A recommended number of assays is 30. Then, calculate candidate equivalence margins for all of the supported similarity tests in PLA 3.0.
The method supported by PLA 3.0 is a preferred method to calculate equivalence margins and is supported by the US Pharmacopeia <1032>.
- Estimation of equivalence margins for a nonlinear quantitative response assay based on 24 historical data sets.