Deviation in maintaining Fed breakfast [Study Per­for­mance]

posted by Pankaj – India, 2010-08-16 08:45 (5383 d 18:21 ago) – Posting: # 5791
Views: 3,130
(edited on 2010-08-16 12:23)

Dear Members,
Please give your valuable inputs for the following queries:
  1. Recently carried out one fed study (Europe Submission) where the restriction of 30 minutes from start of breakfast to dosing wasn't maintained (Deviation ranging from 02 to 07 minutes) for more than 50% of the sample size. Now since the clinical part is over, should we go for analysis or to withdraw the subjects samples before start of analysis.
  2. Should a protocol deviation be enough to suffix the problem?
Anticipating your valuable suggestions at the earliest.

Pankaj

Edit: Category changed. [Jaime]

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,668 registered users;
83 visitors (0 registered, 83 guests [including 51 identified bots]).
Forum time: 03:06 CEST (Europe/Vienna)

No matter what side of the argument you are on,
you always find people on your side
that you wish were on the other.    Thomas Berger

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