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Primidone BE study for USFDA submission [Regulatives / Guidelines]

posted by jag009 - NJ, 2018-04-09 16:16  - Posting: # 18656
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Haven't looked up the drug but are both metabolites active? To be on the safe side (if you don't want to file control correspondence) then i would measure the active metabolites since FDA usually ask to have the data collected.

John

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