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Dr_Dan ★★ Germany, 2015-11-03 10:27 (3420 d 01:41 ago) Posting: # 15609 Views: 4,524 |
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Dear all If you develop a new fixed dose combination with known APIs and you have shown BE of the combination against the US mono reference products do you need to repeat the study with European reference products in case you aim not for substitution indication (according to §10(b)) but go for a mixed application according to §8.3? What is your experience? Looking forward to your replies. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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nobody nothing 2015-11-05 16:32 (3417 d 19:36 ago) @ Dr_Dan Posting: # 15614 Views: 3,422 |
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Hi Dan, will be hard to convince EU regulators that the product in the EU is identical to the US product, huh? Maybe start a Sci Adv to get a clue, but don't expect too much, I guess... — Kindest regards, nobody |
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Dr_Dan ★★ Germany, 2015-11-09 09:48 (3414 d 02:20 ago) @ nobody Posting: # 15627 Views: 3,196 |
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Dear nobody As I explained, it is a new fixed dose combination with known APIs, there is no reference product in the strict sense, only mono product references but if you do not aim for substitution indication (according to §10(b)) but go for a mixed application according to §8.3 do you need to demonstrate BE against the European mono products? Looking forward to your reply. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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nobody nothing 2015-11-10 15:01 (3412 d 21:07 ago) @ Dr_Dan Posting: # 15628 Views: 3,103 |
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Hi Dan, as far as I was concerned: Yes, you have to show anything against a product with a European marketing authorization. No way around that, in my opinion. But as I said: Sci Adv. will help a lot  — Kindest regards, nobody |
Ing. Helmut Schütz