FDA on Truncated AUC [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2012-07-25 19:28 (5084 d 06:24 ago) – Posting: # 8982
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Hi John,

❝ The part I am not comfortable about is when FDA stated that "For drugs demonstrating high intrasubject variability in distribution and clearance, AUC truncation warrants caution." Are they referring to highly variable drugs?


I guess (!!) so.

❝ PS. Regarding the multiple blanks in my previous post.... You don't see it now right?


… because I deleted them in all your previous posts (and this one as well).

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