Enoxaparin sodium injection BA BE studies [Regulatives / Guidelines]

posted by varsha chungde – India, 2018-10-10 07:09 (1111 d 21:57 ago) – Posting: # 19423
Views: 2,546

» 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The draft guidance says that we need to prove the sameness between API.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
21,757 posts in 4,549 threads, 1,544 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Tuesday 05:07 CEST (Europe/Vienna)

I have never in my life learned anything
from any man who agreed with me.    Dudley Field Malone

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