Bioequivalence and Bioavailability Forum 00:39 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

BA BE Study with a reference not market authorised [Regulatives / Guidelines]

posted by Rick - Italy, 2017-10-10 16:20  - Posting: # 17883
Views: 1,685

Hello to all.
My question is:

Is it possible to conduct a BE or BA studies without a market authorised product as a reference?

I have a new formulation (NF) of a product (P) that has been demonstrated to be BE to a reference Marketed (RM) product, but it is not authorised. And I want to demonstrate BE of my new formulation (NF) vs the product (P) already BE to the Market authorised (RF).

Is it acceptable from a regulatory point of view?

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,697 posts in 3,982 threads, 1,237 registered users;
online 12 (0 registered, 12 guests [including 10 identified bots]).

Science should always be the basis
of regulatory requirements.    Joachim Röhmel

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