Bioequivalence and Bioavailability Forum

Dear Charl and HS,

❝ 'Incurred Sample Re-analysis' (is this really English?)

US English, it seems

I attended the AAPS/FDA workshop in Crystal City last year. FDA only stated that they wanted precision to be demonstrated on "incurred samples", not just on artificial, spiked samples. They declined to detail how they wanted it to be done, saying it was the responsibility of the people in the lab and of the sponsor, based on their best scientific jugement. Basically it seems this all comes from FDA findings during inspections of bioequivalence trials (at least at MDS in Canada, from the letters they have issued), but FDA just don't know exactly themselves how it should be done (said they don't have enough data at this stage) and how they will interpret the results

A representative from Canada HPB was asked why they dropped the requirement for 15 % random reassay. The response was quite simple and straightforward: because they just didn't know what to do with the data and there was no established acceptance criteria

Regards
Ohlbe