Parent Drug and Active Metabolite [Regulatives / Guidelines]

posted by joyjac – Philippines, 2006-05-09 09:45 (6611 d 07:54 ago) – Posting: # 120
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FDA CDER Guidance states that if the parent drug can be measured, the confidence interval should be applied to the parent drug but data of the active metabolite must be submitted to provide evidence of comparable therapeutic outcome. Does this mean we need to calculate also the 90% CI for the active metabolite? What if the 90% CI for the parent drug falls within the BE limit but Not for the active metabolite? Highly appreciate your insight on this BE issue. Thanks.

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