nobody nothing 2016-04-27 11:22 (2918 d 11:55 ago) Posting: # 16246 Views: 2,831 |
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Hi everybody! Wanna do a BE trial for EU, but there is no orignator's product on the market (any more), what is the solution? — Kindest regards, nobody |
Helmut ★★★ Vienna, Austria, 2016-04-27 13:38 (2918 d 09:39 ago) @ nobody Posting: # 16247 Views: 2,287 |
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Hi nobody, ❝ Wanna do a BE trial for EU, but there is no orignator's product on the market (any more), what is the solution? Too bad. See the BE-GL Section 4.1.2 and the referred Directive 2001/83/EC Article 8. I once succeeded with a reference product which was registered in a member state of the EEA (Switzerland) – but it was a hell of paper work and a hybrid application (PK + clinical study). Don’t think that it would be acceptable in ‘pure’ BE. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
nobody nothing 2016-04-27 14:01 (2918 d 09:16 ago) @ Helmut Posting: # 16248 Views: 2,245 |
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Hihihi, exactly what I had in mind on this... — Kindest regards, nobody |
Dr_Dan ★★ Germany, 2016-04-27 17:42 (2918 d 05:36 ago) @ nobody Posting: # 16250 Views: 2,288 |
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Dear nobody In applications for generic medicinal products according to Directive 2001/83/EC, Article 10(1) bioequivalence needs to be demonstrate between the generic medicinal product and a reference medicinal product in order to allow bridging of preclinical tests and of clinical trials associated with the reference medicinal product. How do you want to make a reference if no originator exists? In such a case you have to provide pre-clinical and clinical data for safety and efficacy. I hope this helps Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
nobody nothing 2016-04-27 18:31 (2918 d 04:47 ago) @ Dr_Dan Posting: # 16251 Views: 2,227 |
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Hi Dan! ❝ In applications for generic medicinal products according to Directive 2001/83/EC, Article 10(1) .... Yeah, but sometimes you do BE for applications according to other Articles.... Tricky sometimes... — Kindest regards, nobody |