What's the problem? [Regulatives / Guidelines]

posted by nobody – 2017-05-17 07:48  – Posting: # 17362
Views: 17,313

» ...If you have 20 reports with a CV of 11% and one with a CV of 41% then you start wondering.

OK, and (as a regulator) what are the options? Start an inspection of the CRO? Find some other "good reason" not to grant MA to the pile of trash high quality generic developed in a scientifically advanced pharmaceutical company with cutting edge technology?

Kindest regards, nobody

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,404 posts in 4,122 threads, 1,323 registered users;
online 6 (1 registered, 5 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 19:05 CEST

Those people who think they know everything
are a great annoyance to those of us who do.    Isaac Asimov

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5