biowaiver for higher strength [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2022-01-24 11:01 (246 d 12:03 ago) – Posting: # 22750
Views: 1,178

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.

Complete thread:

UA Flag
 Admin contact
22,391 posts in 4,685 threads, 1,595 registered users;
online 4 (0 registered, 4 guests [including 4 identified bots]).
Forum time: Wednesday 00:05 CEST (Europe/Vienna)

The real struggle is not between the right and the left
but between the party of the thoughtful
and the party of the jerks.    Jimmy Wales

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