AB rating & bioequivalence [Regulatives / Guidelines]

posted by mayur661 – India, 2018-11-13 08:33 (887 d 16:20 ago) – Posting: # 19592
Views: 1,410

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:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,509 registered users;
online 10 (0 registered, 10 guests [including 4 identified bots]).
Forum time: Monday 00:53 UTC (Europe/Vienna)

There is one certainty in drug development
and statistics that one can depend on:
the data are always late.    Scott Patterson and Byron Jones

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