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 (2025 d 04:18 ago) – Posting: # 19418
Views: 3,231

❝ 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

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