Ezetimibe final guidance [Regulatives / Guidelines]

posted by Ohlbe – France, 2019-09-30 11:03  – Posting: # 20655
Views: 589

Dear Helmut,

» One should indeed measure both ezetimibe and its glucuronide. BE should be based on their sum only.

» Both methods have errors (inaccurate, imprecise). If you evaluate the sum of concentrations, errors will sum up as well.

Well... It depends how you measure the glucuronide. If you have a direct method (which is a bit of a challenge), that's true, but the fact that

» the concentrations of the glucuronide are two orders of magnitude higher than the parent’s

will limit the impact.

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 ?

Regards
Ohlbe

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