Bioequivalence and Bioavailability Forum • WHO Guidelines draft, April 2014

WHO Guidelines draft, April 2014 [Regulatives / Guidelines]

posted by wien-ui – Oman, 2014-06-18 22:45 (4385 d 06:48 ago) – Posting: # 13088
Views: 4,069

Hi Helmut and ElMaestro,

I can't find anything in this draft indicates removing of subjects add on Design, like the EMA (May 2012)? has the WHO decided to keep it also valid?
I thought the reason of establishing the two-stage sequential designs is as they give better control of patient's risk than the add on design.
Best regards,
Osama

Complete thread:

WHO Guidelines draft, April 2014 wien-ui 2014-06-11 18:32 [Regulatives / Guidelines]
- WHO Guidelines draft, April 2014 wien-ui 2014-06-14 09:44
  - Two-Stage Designs Helmut 2014-06-16 13:14
    - interim analysis, wording ElMaestro 2014-06-16 13:41
      - interim analysis, wording Helmut 2014-06-16 14:11
- WHO Guidelines draft, April 2014wien-ui 2014-06-18 20:45
  - No Add-on studies Helmut 2014-06-22 14:31