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

posted by ElMaestro  – Denmark, 2019-05-22 18:11 (1941 d 03:19 ago) – Posting: # 20295
Views: 6,669

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:

UA Flag
Activity
 Admin contact
23,224 posts in 4,878 threads, 1,654 registered users;
26 visitors (0 registered, 26 guests [including 6 identified bots]).
Forum time: 21:30 CEST (Europe/Vienna)

One of the symptoms of an approaching nervous breakdown
is the belief that one’s work is terribly important.    Bertrand Russell

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