Ezetimibe BE [Regulatives / Guidelines]

posted by Mutasim – Jordan, 2019-09-23 14:40  – Posting: # 20641
Views: 900

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]

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