Enoxaparin sodium injection BA BE studies [Regulatives / Guidelines]

posted by varsha chungde – India, 2018-10-10 07:09 (830 d 14:05 ago) – Posting: # 19423
Views: 2,202

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The draft guidance says that we need to prove the sameness between API.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

 Admin contact
21,303 posts in 4,441 threads, 1,487 registered users;
online 4 (0 registered, 4 guests [including 4 identified bots]).
Forum time: Sunday 20:15 CET (Europe/Vienna)

No problem can stand the assault of sustained thinking.    Voltaire

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