Enoxaparin sodium injection BA BE studies [Regulatives / Guidelines]

posted by varsha chungde – India, 2018-10-08 11:34 (1115 d 01:35 ago) – Posting: # 19415
Views: 3,011

Hi all,

As per guideline we need not to perform any Bioequivalence studies for Injectables. But Enoxaparin sodium being a biologically derived product, is there any need of performing the BA-BE studies.

Does the guideline differs for a biologically derived product?:confused::confused:confused:

Complete thread:

Activity
 Admin contact
21,758 posts in 4,550 threads, 1,545 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Wednesday 13:10 CEST (Europe/Vienna)

There ain’t no rules around here!
We’re trying to accomplish something!    Thomas Alva Edison

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