Enoxaparin sodium injection BA BE studies [Regulatives / Guidelines]

posted by varsha chungde – India, 2018-10-08 09:34 (986 d 02:48 ago) – Posting: # 19415
Views: 2,850

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:

 Admin contact
21,530 posts in 4,499 threads, 1,523 registered users;
online 17 (0 registered, 17 guests [including 1 identified bots]).
Forum time: Sunday 12:23 UTC (Europe/Vienna)

Intellect distinguishes between the possible and the impossible;
reason distinguishes between the sensible and the senseless.
Even the possible can be senseless.    Max Born

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