Enoxaparin sodium injection BA BE studies [Regulatives / Guidelines]

posted by nobody – 2018-10-09 12:42 (2082 d 12:46 ago) – Posting: # 19418
Views: 3,403

❝ 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

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[…] an inappropriate study design is incapable of answering
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