biowaiver for higher strength [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2022-01-24 12:01 (794 d 07:48 ago) – Posting: # 22750
Views: 2,188

Hi John!
Interesting question but when we revisit guidelines, the biowaiver recommendation is mostly for lower strength formulation only. I believe that the criteria of not using higher strength due to safety/AE if justifiable, then may be used to support waiver using lower strength.
Regards,
Dshah

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
93 visitors (0 registered, 93 guests [including 10 identified bots]).
Forum time: 19:49 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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