Bioequivalence and Bioavailability Forum • Enoxaparin sodium injection BA BE studies

Enoxaparin sodium injection BA BE studies [Regulatives / Guidelines]

posted by nobody – 2018-10-09 12:42 (1701 d 01:54 ago) – Posting: # 19418
Views: 2,935

❝ 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:

Enoxaparin sodium injection BA BE studies varsha chungde 2018-10-08 11:34 [Regulatives / Guidelines]
- BE of parenterals Helmut 2018-10-08 11:53
- Enoxaparin sodium injection BA BE studiesnobody 2018-10-09 10:42
  - Enoxaparin sodium injection BA BE studies varsha chungde 2018-10-10 07:09
- Enoxaparin sodium injection BA BE studies ElMaestro 2018-10-09 11:13
  - Enoxaparin sodium injection BA BE studies varsha chungde 2018-10-10 07:11

Admin contact
22,618 posts in 4,741 threads, 1,611 registered users;
16 visitors (1 registered, 15 guests [including 6 identified bots]).
Forum time: 14:37 CEST (Europe/Vienna)

There are in fact two things, science and opinion;
the former begets knowledge, the latter ignorance. Hippocrates

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz