subject withdrawn after bioanalysis [Study As­sess­ment]

posted by anbu – India, 2018-09-12 10:17  – Posting: # 19269
Views: 1,146

A subject had vomited within the 2 times of tmax period, as per pk person discussion, he continued and completed the study. After bioanalysis of the sample again pk persons, taking decision to withdraw a subject. does this procedure is fine? kindly explain the same.


Edit: Category changed; see also this post #1. Please follow the Forum’s Policy[Helmut]

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,537 posts in 4,144 threads, 1,338 registered users;
online 11 (0 registered, 11 guests [including 7 identified bots]).
Forum time (Europe/Vienna): 01:05 CEST

When puzzled, it never hurts to read the primary documents –
a rather simple and self-evident principle that has, nonetheless,
completely disappeared from large sectors
of the American experience.    Stephen Jay Gould

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5