Bioequivalence and Bioavailability Forum • Ezetimibe final guidance

Ezetimibe final guidance [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2019-09-30 17:33 (1668 d 19:40 ago) – Posting: # 20658
Views: 4,279

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.

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Helmut Schütz

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Complete thread:

Ezetimibe BE Mutasim 2019-09-23 14:40
- 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 guidance Ohlbe 2019-09-30 11:03
    - Ezetimibe final guidanceHelmut 2019-09-30 15:33
- Ezetimibe BE ElMaestro 2019-09-30 13:12
  - Ezetimibe BE Helmut 2019-09-30 15:26