Reference=originator [Study Per­for­mance]

posted by Dr_Dan  – Germany, 2010-09-22 11:34 (5750 d 09:29 ago) – Posting: # 5930
Views: 5,422

Dear all
For a generic product the marketing authorisation applications reference must be made to the dossier of a reference medicinal product for which a marketing authorisation is or has been granted on the basis of a complete dossier. In other words: The reference product is always the innovator product.
Kind regards
Dan

Kind regards and have a nice day
Dr_Dan

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
148 visitors (0 registered, 148 guests [including 43 identified bots]).
Forum time: 21:04 CEST (Europe/Vienna)

I have finally come to the konklusion
that a good reliable set ov bowels
iz worth more to a man
than enny quantity of brains.    Josh Billings

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