Bioequivalence and Bioavailability Forum 13:19 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: 13,067

» ...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
18,881 posts in 4,026 threads, 1,271 registered users;
online 29 (0 registered, 29 guests [including 21 identified bots]).

Being ignorant is not so much a shame,
as being unwilling to learn.    Benjamin Franklin

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