No way [Dissolution / BCS / IVIVC]

posted by yuvaneshwari – India, 2019-01-28 04:16 (868 d 23:35 ago) – Posting: # 19815
Views: 1,778

Thanks for your response. I was hoping to justify the waiver on the basis of sameness of finished test product against reference. I understand that criticality still remain since the molecule is BCS II drug. Thank you.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]

Complete thread:

Activity
 Admin contact
21,518 posts in 4,498 threads, 1,524 registered users;
online 5 (0 registered, 5 guests [including 5 identified bots]).
Forum time: Tuesday 03:51 UTC (Europe/Vienna)

I suppose it is tempting, if the only tool you have is a hammer,
to treat everything as if it were a nail.    Abraham Maslow

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