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RegisterEzetimibe BE [Regulatives / Guidelines]
Dear Members,
Would you please advice on interpretation of the requirements for Ezetimibe BE according to the last guidance by EMA, in particular the statement
"Main pharmacokinetic variables: AUC0-72h, Cmax
Background/justification: On total (parent + glucuronide metabolite together)
Does it mean measuring each one alone? or the total as in FDA guidance? and accordingly will the CI be for each one alone or both unconjugated and total or only total?
Edit: Guideline linked. [Helmut]
Would you please advice on interpretation of the requirements for Ezetimibe BE according to the last guidance by EMA, in particular the statement
"Main pharmacokinetic variables: AUC0-72h, Cmax
Background/justification: On total (parent + glucuronide metabolite together)
Does it mean measuring each one alone? or the total as in FDA guidance? and accordingly will the CI be for each one alone or both unconjugated and total or only total?
Edit: Guideline linked. [Helmut]
Complete thread:
- Ezetimibe BEMutasim 2019-09-23 14:40
![[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 guidance Ohlbe 2019-09-30 11:03
- Ezetimibe final guidance Helmut 2019-09-30 15:33
- Ezetimibe final guidance Ohlbe 2019-09-30 11:03
- Ezetimibe BE ElMaestro 2019-09-30 13:12
- Ezetimibe BE Helmut 2019-09-30 15:26
Ing. Helmut Schütz