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Comparative PK [Study Performance]

posted by PVRC – India, 2021-05-10 20:12 (1439 d 15:53 ago) – Posting: # 22338
Views: 4,109

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....

Complete thread:

Comparative PKPVRC 2021-05-10 18:12
- 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

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Comparative PK [Study Per­for­mance]

Complete thread:

Comparative PK [Study Performance]