BE assessment regarding first time point Cmax [Study As­sess­ment]

posted by Erkin – Turkey, 2018-12-28 08:29  – Posting: # 19717
Views: 1,651

Dear Mann,

I've found the following on page 298 of "Generic Drug Product Development - Solid Oral Dosage Forms" by Leon Shargel & Isadore Kanfer":

First point Cmax: Do any of the concentrations vs. time profiles exhibit first-point Cmax (i.e., the first sample collected is the Cmax value)?
If so, were 3 to 5 samples collected within the first hour and was one of these collected between 5 and 15 minutes post-dose?
If these early samples were collected, no change in data analysis is warranted.
If these early samples were not collected, then those subjects with first point Cmax values should be dropped from the primary statistical analysis.


I couldn't find the reference from EMA or FDA about dropping the subjects. I've contacted to Dr. Leon Shargel via e-mail and asked him the same question.

I will post here, as soon as he replied me.

Regards,
Erkin

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