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RegisterBA 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?
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?
Complete thread:
- BA BE Study with a reference not market authorisedRick 2017-10-10 16:20 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BA BE Study with a reference not market authorised ElMaestro 2017-10-10 17:09
- BA BE Study with a reference not market authorised Rick 2017-10-11 09:07
- BA BE Study with a reference not market authorised ElMaestro 2017-10-10 17:09
Ing. Helmut Schütz