Helmut
★★★
avatar
Homepage
Vienna, Austria,
2023-08-29 13:18
(103 d 21:11 ago)

Posting: # 23708
Views: 787
 

 WHO Draft on BCS-based Biowaivers [BE/BA News]

Dear all,

the WHO published a draft working document for public consultation last July. Sorry that I discovered it that late (THX to Susana Al­meida of Medicines for Europe). It contradicts partly ICH M9 of Nov 2019

Comments should be submitted by 31 August 2023.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
UA Flag
Activity
 Admin contact
22,823 posts in 4,786 threads, 1,633 registered users;
28 visitors (0 registered, 28 guests [including 7 identified bots]).
Forum time: 09:29 CET (Europe/Vienna)

In these matters the only certainty is
that nothing is certain.    Pliny the Elder

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5