Bioequivalence and Bioavailability Forum • New FDA BMV guideline

New FDA BMV guideline [BE/BA News]

posted by Ohlbe – France, 2018-05-21 18:28 (2949 d 22:01 ago) – Posting: # 18793
Views: 12,806

Dear all,

The FDA have just published their revised guidance on bioanalytical method validation.

Strange, considering that the ICH M10 guideline is on its way. I somehow thought that the FDA guideline had been put on hold.

—
Regards
Ohlbe

Complete thread:

New FDA BMV guidelineOhlbe 2018-05-21 16:28
- What a monster! Helmut 2018-05-21 17:47
  - What a monster! jag009 2018-05-24 03:19
    - Two Versions: May 21 & May 24 Obinoscopy 2018-07-29 18:13
- Repeats as part of investigations, ja oder nein? ElMaestro 2018-05-22 00:17
  - Repeats as part of investigations, ja oder nein? Ohlbe 2018-05-22 12:02
    - Two Versions: May 21 & May 24 Obinoscopy 2018-07-30 20:41
      - Requirements ⇒ recommendations Helmut 2018-08-01 11:12
        
        Requirements ⇒ recommendations Obinoscopy 2018-08-02 22:59