Bioequivalence and Bioavailability Forum

Enoxaparin sodium injection BA BE studies [Regulatives / Guidelines]

posted by varsha chungde – India, 2018-10-08 13:34 (2821 d 19:58 ago) – Posting: # 19415
Views: 5,826

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:

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