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RegisterEzetimibe final guidance [Regulatives / Guidelines]
Dear Helmut,
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
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 ?
❝ 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
Regards
Ohlbe
Complete thread:
- Ezetimibe BE Mutasim 2019-09-23 14:40 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Ezetimibe BE Helmut 2019-09-23 15:36
- Confusing guidance Helmut 2019-09-25 11:52
- Confusing guidance nobody 2019-09-25 13:36
- Ezetimibe final guidance Helmut 2019-09-28 12:11
- Ezetimibe final guidanceOhlbe 2019-09-30 11:03
- Ezetimibe final guidance Helmut 2019-09-30 15:33
- Ezetimibe final guidanceOhlbe 2019-09-30 11:03
- Ezetimibe BE ElMaestro 2019-09-30 13:12
- Ezetimibe BE Helmut 2019-09-30 15:26
Ing. Helmut Schütz