Bioequivalence and Bioavailability Forum • FDC or isomers: C0

FDC or isomers: C0 > 5 % of Cmax [Regulatives / Guidelines]

posted by Achievwin – US, 2024-08-05 21:08 (276 d 21:58 ago) – Posting: # 24134
Views: 2,389

❝ The ICH’s M13A will soon supersed the FDA’s guidance. However, a similar procedure is stated in its Section 2.2.3.3 Carry over.

❝

❝ The idea of assessing the predose concentrations in higher period(s) is to check whether the washout was sufficiently long. The treatment comparison in the presence of equal/unequal carryover would – unavoidably – be biased and there is no statistical method to adjust for it.

Oh my equal/unequal carryover – never ending story

Complete thread:

Predose concentration more than 5 % of Cmax NK 2024-08-05 06:07
- FDC or isomers: C0 > 5 % of Cmax Helmut 2024-08-05 08:36
  - FDC or isomers: C0 > 5 % of CmaxAchievwin 2024-08-05 19:08
    - Carryover. A Never Ending Story. Helmut 2024-08-05 22:39
  - Inducers/inhibitors Ohlbe 2024-08-08 18:09
    - Inducers/inhibitors Helmut 2024-08-09 08:26
- Predose concentration more than 5 % of Cmax qualityassurance 2024-08-05 12:48