Enoxaparin sodium injection BA BE studies [Regulatives / Guidelines]

posted by nobody – 2018-10-09 10:42 (1115 d 02:20 ago) – Posting: # 19418
Views: 2,623

» As per guideline we need not to perform any Bioequivalence studies for Injectables.

That's simply not true at all.

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

Kindest regards, nobody

Complete thread:

Activity
 Admin contact
21,760 posts in 4,550 threads, 1,545 registered users;
online 4 (0 registered, 4 guests [including 4 identified bots]).
Forum time: Thursday 13:03 CEST (Europe/Vienna)

Always remember that you are absolutely unique.
Just like everyone else.    Margaret Mead

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