Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-12-12 21:57 UTC (UTC+2h)
 

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

posted by Rick - Italy, 2017-10-10 14:20  - Posting: # 17883
Views: 663

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
17,555 Posts in 3,758 Threads, 1,089 registered users;
31 users online (0 registered, 31 guests).

Enlightenment is man’s emergence from his self-imposed nonage
for which he himself was responsible.
Nonage is the inability to use one’s own intellect
without the direction of another.    Immanuel Kant

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