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Rick ☆ Italy, 2017-10-10 18:20 (2380 d 01:40 ago) Posting: # 17883 Views: 3,538 |
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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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ElMaestro ★★★ Denmark, 2017-10-10 19:09 (2380 d 00:51 ago) @ Rick Posting: # 17884 Views: 2,977 |
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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? — Pass or fail! ElMaestro |
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Rick ☆ Italy, 2017-10-11 11:07 (2379 d 08:53 ago) @ ElMaestro Posting: # 17886 Views: 2,955 |
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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] |
Ing. Helmut Schütz