Cmax [General Sta­tis­tics]

posted by DavidManteigas – Portugal, 2016-08-08 13:10 (3104 d 20:17 ago) – Posting: # 16540
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Assuming that you're asking about widening the acceptance criteria, at least for EMA and FDA that would be impossible. The definition of highly variable drugs is clear in both EMA and FDA guidances. No drug is considered highly variable by itself. In fact, the same drug could be highly variable in one study and fail to met the criteria in another different study. As far as I know, fed studies likely produce results with higher variability so the same drug may be considered "highly variable" in the fed study but fail to met the criteria for the fasting study.

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