Method not sensitive enough [Study As­sess­ment]

posted by Aymanmy – Jordan, 2019-12-18 17:58 (644 d 10:32 ago) – Posting: # 21001
Views: 2,401

Hi Helmut and colleagues
thanks for your replies and interactions,
my concern is the study is already submitted by the sponsor to the H.A, and the study results are known, also the samples are out of studied long term stability, can we just exclude the results of the affected subjects from the statistics?
and plz to confirm that every individual subject should fulfil the less than 5% of Cmax criteria for the future?

thanks again very much for your inteaction, its highly appreciated.

Complete thread:

Activity
 Admin contact
21,691 posts in 4,534 threads, 1,541 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Thursday 05:31 CEST (Europe/Vienna)

Learning is a lifetime process, but there comes a time
when we must stop adding and start updating.    Robert Brault

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5