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Back to the forum  Query: 2018-02-19 04:33 CET (UTC+1h)
 

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

posted by Rick - Italy, 2017-10-10 16:20  - Posting: # 17883
Views: 901

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?

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