No correction if ≤5% Cmax [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2012-04-05 18:08 (3580 d 11:43 ago) – Posting: # 8390
Views: 8,349

Hi John!

» […] can the pre-dose (0 hr) concentration be set to 0 if it is less than 5% of Cmax? FDA that is...

Can? Technically, yes. But I wouldn’t recommend it (see the [image] 2003 guidance):(my emphasis; interpreting “can” as “should”…)

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