Impartial Witness in BABE study [GxP / QC / QA]

posted by ElMaestro  – Denmark, 2019-05-22 16:11 (982 d 23:22 ago) – Posting: # 20295
Views: 4,630

Hi yatish gosai
and all posters on this thread,

to be honest I think this is a great, great question and it is one that made me think very hard for a prolonged moment.

The mere fact that such a question is asked should give rise to a lot of reflection on the part of regulators. What is obvious to a regulator or someone from one geographical region is obviously not obvious to others. At the end of the day guidelines are not intended solely for regulators but for all involved parties.

So here's something to work with.

Pass or fail!
ElMaestro

Complete thread:

Activity
 Admin contact
21,858 posts in 4,574 threads, 1,554 registered users;
online 17 (0 registered, 17 guests [including 17 identified bots]).
Forum time: Saturday 14:33 CET (Europe/Vienna)

Truth in science can be defined as the working hypothesis best suited
to open the way to the next better one.    Konrad Lorenz

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