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RegisterIVRT or IVPT BE studies [Regulatives / Guidelines]
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
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
Complete thread:
- IVRT or IVPT BE studies jag009 2019-07-22 22:59 [Regulatives / Guidelines]
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Ing. Helmut Schütz