Bioequivalence and Bioavailability Forum

Comparative PK? [Study Performance]

posted by PVRC – India, 2021-05-20 09:41 (930 d 23:44 ago) – Posting: # 22361
Views: 1,603

❝ can you give us the context? Which guidance are you referring to (a link would be nice)? Did you really fail to show BE?

Hi Helmut,

the description given is not from the guidance but from the responses from FDA to one of the questions in the pIND meeting. FDA recommended to demonstrate comparable PK in case bioequivalence is not established for different reasons in the fasted and fed state.

Thanks with best regards

Complete thread:

Comparative PK PVRC 2021-05-10 18:12 [Study Performance]
- 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? [Study Per­for­mance]

Complete thread:

Comparative PK? [Study Performance]