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Back to the forum  Query: 2017-12-14 01:45 CET (UTC+1h)
 

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

posted by ElMaestro - Denmark, 2017-10-10 17:09  - Posting: # 17884
Views: 562

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.

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