Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

Published ! [Regulatives / Guidelines]

posted by kumarnaidu – Mumbai, India, 2014-11-28 07:20 (4230 d 20:37 ago) – Posting: # 13939
Views: 4,155

Thanks Ohlbe for sharing guidance.
The date for coming into effect for this guidance is 1 June 2015. Can we submit the study as per the old guidance (without pAUC) now? :-D

—
Kumar Naidu

Complete thread:

EMA MR guideline Ohlbe 2014-11-18 22:55 [Regulatives / Guidelines]
- Published ! Ohlbe 2014-11-27 19:22
  - Published !kumarnaidu 2014-11-28 06:20
    - Published ! Ohlbe 2014-11-28 09:30
      - In effect 1 June 2015 Helmut 2014-11-28 14:11
        
        In effect 1 June 2015 Ohlbe 2014-11-28 18:29
        
        Accumulation Jay 2014-12-01 11:11
        
        Accumulation nobody 2014-12-01 15:48

Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
272 visitors (0 registered, 272 guests [including 21 identified bots]).
Forum time: 04:58 CEST (Europe/Vienna)

Most scientists today are devoid of ideas, full of fear, intent on
producing some paltry result so that they can add to the flood
of inane papers that now constitutes “scientific progress”
in many areas. Paul Feyerabend

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz