Bioequivalence and Bioavailability Forum

FDA: ICH M10 implemented in November 2022 [Bioanalytics]

posted by Helmut  – Vienna, Austria, 2024-12-16 13:38 (158 d 13:33 ago) – Posting: # 24315
Views: 1,435

Hi Rasha,

❝ Does the adoption of ICH M10 makes FDA 2018 guideline obsoleted for bioanalytical method validation?

Yes, it does.

❝ Unlike the EMA, which has clearly stated that ICH M10 replaces its existing guideline, the FDA does not appear to have made a similar announcement

Right. See the end of this post. That’s one of the many traps of the .

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• Recovery testing Rasha 2024-12-16 10:29 
  • FDA: ICH M10 implemented in November 2022Helmut 2024-12-16 12:38
    • FDA: ICH M10 implemented in November 2022 Rasha 2024-12-16 13:15