Bioequivalence and Bioavailability Forum • ISR

ISR [Bioanalytics]

posted by Ohlbe – France, 2012-12-17 23:53 (4546 d 06:04 ago) – Posting: # 9727
Views: 8,400

Dear all,

❝ The EGA (European Generic Association) sent a letter to the CMDh asking for a clarified joint statement by the EMA PKWP and the CMDh regarding the retrospective application of the bioanalytical method validation guideline for all studies performed (and completed) before finalisation of the guideline and already part of approved dossiers.

Update of the PKWP Q&A published.

Regards
Ohlbe

—
Regards
Ohlbe

Complete thread:

ISR The Outlaw Torn 2012-11-29 15:58
- ISR Dr_Dan 2012-11-29 16:30
  - ISR The Outlaw Torn 2012-11-30 07:53
  - ISROhlbe 2012-12-17 22:53
    - ISR The Outlaw Torn 2012-12-18 08:09
    - 90% CI riddle Helmut 2012-12-18 17:12
      - 90% CI riddle The Outlaw Torn 2012-12-19 07:49
        
        90% CI riddle Dr_Dan 2012-12-20 09:45
        
        90% CI riddle The Outlaw Torn 2012-12-20 11:23
        
        90% CI riddle Dr_Dan 2012-12-20 12:58