Enoxaparin sodium injection BA BE studies [Regulatives / Guidelines]

posted by varsha chungde – India, 2018-10-10 07:09 (944 d 03:09 ago) – Posting: # 19423
Views: 2,347

» There is a (draft) US guidance on BE for enoxaparine. Good starting point. Have fun!

The draft guidance says that we need to prove the sameness between API.


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 #5[Helmut]

Complete thread:

Activity
 Admin contact
21,446 posts in 4,483 threads, 1,511 registered users;
online 11 (0 registered, 11 guests [including 7 identified bots]).
Forum time: Tuesday 10:19 CEST (Europe/Vienna)

The fact that some geniuses were laughed at
does not imply that all who are laughed at are geniuses.    Carl Sagan

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