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Back to the forum  Query: 2018-05-25 09:19 CEST (UTC+2h)
 
Rick
Junior

Italy,
2017-10-10 16:20

Posting: # 17883
Views: 1,199
 

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

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?
ElMaestro
Hero

Denmark,
2017-10-10 17:09

@ Rick
Posting: # 17884
Views: 1,038
 

 BA BE Study with a reference not market authorised

Hi Rick,

» 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).

This is a regular type II variation or a line extension depending on whether P stays on the market after you introduce NF.
If you are not the MA holder for P then the situation is not in any way straightforward. At the end of the day the reference should be an article 8 approved product and judging from your question P might not be?!??. Let us hear some more details, please. Ideally name the RF product :-):-)

Can you elaborate on the passage "(...) it is not authorised": What does "it" refer to, is it P, NF or RM?

“A ten-year, double-blind study from the Mayo Clinic concluded that even in late stages of dementia, the last to go is the lobe of the brain in charge of cafeteria layout.” (Serge Storms/Tim Dorsey).


Best regards,
ElMaestro

- Bootstrapping is a relatively new hobby of mine. I am only 30 years late to the party.
Rick
Junior

Italy,
2017-10-11 09:07
(edited by Ohlbe on 2017-10-11 10:21)

@ ElMaestro
Posting: # 17886
Views: 994
 

 BA BE Study with a reference not market authorised

thank you.

» Can you elaborate on the passage "(...) it is not authorised": What does "it" refer to, is it P, NF or RM?

The not authorized is NF (of curse: it is my test) and also P, at the same time RM is not authorized in the country where i want to proceed with my trial.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
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