Bioequivalence and Bioavailability Forum 04:13 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

What's the problem? [Regulatives / Guidelines]

posted by nobody - 2017-05-17 07:48  - Posting: # 17362
Views: 15,489

» ...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
19,037 posts in 4,061 threads, 1,300 registered users;
online 9 (0 registered, 9 guests [including 8 identified bots]).

An expert is a man who has made all the mistakes,
which can be made, in a very narrow field.    Niels Bohr

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