Bioequivalence and Bioavailability Forum • in vivo ≠ in vitro

in vivo ≠ in vitro [Power / Sample Size]

posted by Mithu – India, 2022-07-25 15:26 (1082 d 21:28 ago) – Posting: # 23175
Views: 4,248

❝ As per regulatory acceptance- it is either acceptable or unacceptable. So is not best to describe it as marginally acceptable.

Just to make it clear that I am trying to say that study is passing at 80.5% lower CI.

❝ The in vitro assessment with recent batches of reference is important and also performing a comparative dissolution with older lot (if still available) can be useful.

❝

❝ Taking only larger size without consideration of in vitro assessment will not solve your problem.

Thank you.

Regards,

Complete thread:

BCS Class II & IV molecule Mithu 2022-07-25 06:39 [Power / Sample Size]
- BCS Class II & IV molecule dshah 2022-07-25 09:44
  - BCS Class II & IV molecule Mithu 2022-07-25 10:56
- in vivo ≠ in vitro Helmut 2022-07-25 09:56
  - in vivo ≠ in vitro Mithu 2022-07-25 10:54
    - in vivo ≠ in vitro dshah 2022-07-25 11:19
      - in vivo ≠ in vitroMithu 2022-07-25 13:26
    - Assumptions Helmut 2022-07-25 13:02
      - Assumptions Mithu 2022-07-25 13:24