biowaiver for higher strength [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2022-01-24 12:01 (846 d 21:39 ago) – Posting: # 22750
Views: 2,376

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
23,033 posts in 4,835 threads, 1,643 registered users;
36 visitors (1 registered, 35 guests [including 10 identified bots]).
Forum time: 10:40 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

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