volunteer exclusion [Study Per­for­mance]

posted by Dr_Dan  – 2016-02-16 14:12  – Posting: # 15997
Views: 4,797

Dear Yura
Ideally, all treated subjects should be included in the statistical analysis. However, subjects in a crossover trial who do not provide evaluable data for both of the test and reference products (or who fail to provide evaluable data for the single period in a parallel group trial) should not be included. In principle any reason for exclusion of a subject from statistical evaluation is valid provided it is specified in the protocol and the decision to exclude is made before bioanalysis. Exclusion of data cannot be accepted on the basis of statistical analysis or for pharmacokinetic reasons alone, because it is impossible to distinguish the formulation effects from other effects influencing the pharmacokinetics.
I hope this helps.
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan

Complete thread:

Activity
 Admin contact
20,466 posts in 4,298 threads, 1,414 registered users;
online 21 (0 registered, 21 guests [including 2 identified bots]).
Forum time (Europe/Vienna): 04:36 CEST

Learning of many things
does not teach intelligence.    Heraclitus of Ephesus

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