Bioequivalence and Bioavailability Forum • Enoxaparin sodium injection BA BE studies

Enoxaparin sodium injection BA BE studies [Regulatives / Guidelines]

posted by varsha chungde – India, 2018-10-10 09:09 (1699 d 07:05 ago) – Posting: # 19423
Views: 2,865

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The draft guidance says that we need to prove the sameness between API.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

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 studies nobody 2018-10-09 10:42
  - Enoxaparin sodium injection BA BE studiesvarsha 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