IVRT or IVPT BE studies [Regulatives / Guidelines]
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)?
- IVRT or IVPT BE studiesjag009 2019-07-22 22:59 [Regulatives / Guidelines]