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RegisterComparative PK [Study Performance]
Hi all,
For one of the product, the agency recommend to demonstrate comparative PK in the absence of bioequivalence. The question is that whether all bioequivalence criteria (like 80-125%, group effect etc.,) are still applicable to demonstrate comparative PK.
Thanks in advance....
For one of the product, the agency recommend to demonstrate comparative PK in the absence of bioequivalence. The question is that whether all bioequivalence criteria (like 80-125%, group effect etc.,) are still applicable to demonstrate comparative PK.
Thanks in advance....
Complete thread:
- Comparative PKPVRC 2021-05-10 18:12 [Study Performance]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Comparative PK? Helmut 2021-05-12 11:25
- Comparative PK? PVRC 2021-05-12 15:48
- Comparative PK? Helmut 2021-05-12 16:18
- Comparative PK? jag009 2021-05-20 01:31
- Comparative PK? PVRC 2021-05-20 07:41
- Comparative PK? Helmut 2021-05-12 16:18
- Comparative PK? PVRC 2021-05-12 15:48
- Comparative PK? Helmut 2021-05-12 11:25
Ing. Helmut Schütz