Biowaiver for Lower Strength [Regulatives / Guidelines]

posted by Ohlbe – France, 2020-11-23 10:41 (327 d 23:50 ago) – Posting: # 22077
Views: 1,112

Dear vandee,

» Can a BE biowaiver for the lower strength be considered if only the lower strength meets this <5% API of tablet core weight requirement? The higher strength has 5.88% of API content per tablet core weight and passed BE.

The 5% criterion applies to both strengths, lower and higher.

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
21,730 posts in 4,544 threads, 1,543 registered users;
online 12 (0 registered, 12 guests [including 2 identified bots]).
Forum time: Sunday 11:32 CEST (Europe/Vienna)

Be very, very careful what you put into that head,
because you will never, ever get it out.    Thomas Wolsey

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