ANVISA guidance [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2010-04-01 17:34 (4927 d 06:59 ago) – Posting: # 4996
Views: 3,140

Dear Priyanka_S
If you realize, that samples are missing you have to decide before you start your bioanalysis if you want to include this subject into statistical analysis or not. If you do not want to include this subject into statistical analysis (because missing samples occurred around tmax) you do not need to measure the samples (then you are on the safe side). If this subject experienced an AE possibly related with the study medication you have to measure the samples for safety reasons. In this case you have to document clearly that this subject will not be included into statistical analysis.
It is always a disadvantage to exclude a subject, unless you have pre-specified procedures in your study protocol, otherwise the regulatory authority could always ask to present the evaluation with and without that subject.
I hope this helps

Kind regards and have a nice day

Complete thread:

UA Flag
 Admin contact
22,761 posts in 4,775 threads, 1,628 registered users;
10 visitors (0 registered, 10 guests [including 5 identified bots]).
Forum time: 00:33 CEST (Europe/Vienna)

Medical researches can be divided into two sorts:
those who think that meta is better and those
who believe that pooling is fooling.    Stephen Senn

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