Ezetimibe final guidance [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-09-30 15:33  – Posting: # 20658
Views: 1,405

Dear Ohlbe,

I agree with your points about error, etc.

» But if you directly measure total (after deconjugation), and then calculate the glucuronide by substracting unconjugated from total, you won't have this problem. The increased error will affect the glucuronide, but you don't use these concentrations for the determination of bioequivalence.
»
» Wouldn't this be acceptable ?

I don’t know what is acceptable for the agencies. For me, absolutely. I still don’t get the point why one has to present the aglycone at all. Heck, it is not used in the BE assessment.

Cheers,
Helmut Schütz
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