Bioequivalence Study without approved/marketed or no RLD [Regulatives / Guidelines]

posted by ping4santosh  – India, 2020-03-13 10:01 (200 d 00:59 ago) – Posting: # 21263
Views: 1,296

Hello,

If the RLD is unavailable in your country (yet to get register), how would the generic market itself? In EU and middle East, the RLD has to be registered in the target market for the generic to get a chance based on BE. It could be different in China.

What I understand from your draft is that you are the CRO. If sponsor gives you the RLD and test article you can go for pK based study.

Cheers, SKM

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