AB rating & bioequivalence [Regulatives / Guidelines]

posted by mayur661 – India, 2018-11-13 09:33 (682 d 18:55 ago) – Posting: # 19592
Views: 1,352

There are some Oral Solution drug product having AB rating as per Orange book. But for these product there is no OGD recommendation is listed. Whether for this product bio-equivalence study need to be required in ANDA submission.

Complete thread:

 Admin contact
21,076 posts in 4,394 threads, 1,468 registered users;
online 4 (0 registered, 4 guests [including 2 identified bots]).
Forum time: Saturday 05:28 CEST (Europe/Vienna)

For every fact
there is an infinity of hypotheses.    Robert M. Pirsig

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