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RegisterMeets primary objective but not secondary objective [Study Assessment]
As far as Bioequivalence study is concerned there is only a primary objective (no secondary objectives) which is specified in the published BE guidance (in case of FDA), BE acceptance criteria is specified by Regulatory bodies per product. In the absence of a published guidance use the following criteria
1. Fasted and Fed studies
2. BE criteria must be met for 1) Parent drug (unless is not detected) and major circulating active metabolite (it needs to be more than 20% of the parent drug or so),
3. establishing BE for inactive metabolites if they are not major circulating metabolites is only a supportive data)
Hope this helps.
1. Fasted and Fed studies
2. BE criteria must be met for 1) Parent drug (unless is not detected) and major circulating active metabolite (it needs to be more than 20% of the parent drug or so),
3. establishing BE for inactive metabolites if they are not major circulating metabolites is only a supportive data)
Hope this helps.
Complete thread:
- Meets primary objective but not secondary objective Brus 2020-03-27 17:22 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Meets primary objective but not secondary objective kratos 2020-03-31 03:17
- Meets primary objective but not secondary objectiveAchievwin 2020-03-31 21:09
- Meets primary objective but not secondary objective kratos 2020-04-01 02:00
- Meets primary objective but not secondary objective Achievwin 2020-04-06 19:41
- Meets primary objective but not secondary objective kratos 2020-04-01 02:00
Ing. Helmut Schütz