biowaiver for higher strength [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2022-02-03 20:07 (836 d 13:19 ago) – Posting: # 22771
Views: 2,119

Hi John!
From the guideline- "The higher strengths of the test and reference products are proportionally similar to their corresponding lower strength" could be important as if the lower strength 160 mg and higher strength 500 mg are not interchangeable.
Regards,
Dshah

Complete thread:

UA Flag
Activity
 Admin contact
23,033 posts in 4,835 threads, 1,643 registered users;
39 visitors (1 registered, 38 guests [including 6 identified bots]).
Forum time: 10:26 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