Biowaiver criteria - 5% [Regulatives / Guidelines]

posted by Laura Carreiras – Portugal, 2022-08-12 14:03 (1055 d 07:11 ago) – Posting: # 23218
Views: 4,663

Hello everyone!


As described in the bioequivalence guideline:

[image]

I would like to know if anyone has experience with a similar situation. If the active substance is equal to 5.00% of the tablet core weight, can it be considered proportional?

Thank you in advance for the help.

Complete thread:

UA Flag
Activity
 Admin contact
23,425 posts in 4,928 threads, 1,684 registered users;
41 visitors (0 registered, 41 guests [including 12 identified bots]).
Forum time: 21:14 CEST (Europe/Vienna)

No problem can stand the assault of sustained thinking.    Voltaire

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