BE assessment regarding first time point Cmax [Study As­sess­ment]

posted by Erkin – Turkey, 2018-12-28 08:29 (866 d 20:37 ago) – Posting: # 19717
Views: 5,516

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.


Complete thread:

 Admin contact
21,457 posts in 4,485 threads, 1,512 registered users;
online 11 (0 registered, 11 guests [including 5 identified bots]).
Forum time: Thursday 06:07 CEST (Europe/Vienna)

Nothing in the world is more dangerous
than sincere ignorance
and conscientious stupidity.    Martin Luther King, Jr.

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz