FDA: Biowaiver on lower strengths [Regulatives / Guidelines]

posted by wienui  – Germany/Oman, 2018-05-24 17:25 (2217 d 19:52 ago) – Posting: # 18813
Views: 2,396

Hi John,

I'm afraid yes. As the lower test strength have to pass the in vitro comparative dissolution testing vs the high bio-batch (which pass the BE study vs the RLD) test strength.
regards,
Osama

Cheers,
Osama

Complete thread:

UA Flag
Activity
 Admin contact
23,057 posts in 4,840 threads, 1,641 registered users;
127 visitors (1 registered, 126 guests [including 13 identified bots]).
Forum time: 13:18 CEST (Europe/Vienna)

Even though it’s applied science we’re
dealin’ with, it still is – science!    Leslie Z. Benet

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