IVRT or IVPT BE studies [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-07-22 22:59 (464 d 07:31 ago) – Posting: # 20430
Views: 925

Hi,

A strange Q(I know the answer but I was wondering if i am wrong).
Is it possible to run IVRT or IVPT BE studies on two products that are of different strengths? ie: The test is a 2% cream and the RLD is a 10% cream. Why? RLD is not available as a 2% cream. Would the results be acceptable for regulatory filing (FDA or EMA)?

Thx
J

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