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Enoxaparin sodium injection BA BE studies [Regulatives / Guidelines]

posted by varsha chungde – India, 2018-10-08 13:34 (2821 d 07:52 ago) – Posting: # 19415
Views: 5,820

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:

Complete thread:

Enoxaparin sodium injection BA BE studiesvarsha chungde 2018-10-08 11:34
- 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 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

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