Bioequivalence and Bioavailability Forum • in vivo ≠ in vitro

in vivo ≠ in vitro [Power / Sample Size]

posted by Helmut – Vienna, Austria, 2022-07-25 11:56 (633 d 14:02 ago) – Posting: # 23167
Views: 1,898

Hi Mithu,

❝ Is it advisable to have little large sample size …

Larger than what?

❝ … for molecules falls under BCS Class II and IV? especially when routine 2WC design is selected?

Only in a few cases of BCS class II drugs (under certain conditions) there is an in vivo in vitro correlation. For BCS class IV drugs never. You plan the study always based on the in vivo variability and T/R-ratio for a desired power. In other words, BCS does not play any role.

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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 vitroHelmut 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 vitro Mithu 2022-07-25 13:26
    - Assumptions Helmut 2022-07-25 13:02
      - Assumptions Mithu 2022-07-25 13:24