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Unconjugated and total in BE assessment [Regulatives / Guidelines]

posted by durenmatt - 2010-09-22 17:28  - Posting: # 5931
Views: 2,529

Hello,

First time user, very nice and useful website.
I was wondering if someone might be able to offer advice on the need to present unconjugated and total (unconjugated+conjugated) data for EU submission, for compounds such as ursodeoxycholic acid or naloxone, in BE trials. In the case it is, would the expectation be to be within 80-125% limits for all analytes, or would certain analytes be required for supportive information only? For ursodiol (ursodeoxylic acid), FDA clearly requires demonstration of BE on total and unconjugated drug, but the EMA guidance doesn't address conjugation.

Thanks in advance,

Dürenmatt

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