Enoxaparin sodium injection BA BE studies [Regulatives / Guidelines]

posted by varsha chungde – India, 2018-10-10 09:09 (2817 d 17:58 ago) – Posting: # 19423
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❝ 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The draft guidance says that we need to prove the sameness between API.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]

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