Posting: # 19065
on 27 June the ICH released the draft guideline
Biopharmaceutics Classification System-based Biowaivers (M9, step 2).Public consultation is planned for August 2018 and adoption of the final guideline in May 2019.
I’m wondering how this guideline was developed where one of the founding members of ICH (Japan) does not accept BCS-based biowaivers at all…
The quality of responses received is directly proportional to the quality of the question asked. ☼