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

posted by Rick – Italy, 2017-10-10 18:20 (1995 d 15:35 ago) – Posting: # 17883
Views: 3,345

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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