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Back to the forum  Query: 2017-12-11 12:32 CET (UTC+1h)
 
Rick
Junior

Italy,
2017-10-10 16:20

Posting: # 17883
Views: 659
 

 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: 555
 

 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?

I could be wrong, but…


Best regards,
ElMaestro

A potentially biased estimator may be a relevant estimator. The case of REML speaks volumes.
Rick
Junior

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

@ ElMaestro
Posting: # 17886
Views: 506
 

 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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