Aga ☆ US, 2017-01-09 16:13 (2635 d 22:40 ago) Posting: # 16942 Views: 4,569 |
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Hello, Will be bioequivalence study between different strengths (40 mg-test product vs 80 mg-reference) accepted by EU Agencies in generic application? I've searched for guidelines but can't find a definite answer. best regards, Aga |
Dr_Dan ★★ Germany, 2017-01-16 18:40 (2628 d 20:13 ago) @ Aga Posting: # 16958 Views: 3,881 |
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Dear Aga Definition of generic Drug: same API, same route of adminsitration, same strength(s) In consequence your test product is no generic product according to Article 8(3) 2001/83/EC = no generic application. However, you can submit your product as a hybrid application. Hybrid applications under Article 10(3) of Directive 2001/83/EC differ from generic applications in that the results of appropriate pre-clinical tests and clinical trials will be necessary in the following three circumstances:
These applications will thus rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data. Some guidance on the appropriate additional studies required is indicated in Annex IV of the Chapter 1 of the Notice to Applicants. The type of applications mentioned above refer to information that is contained in the dossier of the authorisation of the reference medicinal product, for which a marketing authorisation has been granted in the Union on the basis of a complete dossier in accordance with article 8(3), 10a, 10b or 10c of Directive 2001/83/EC. If you can demonstrate bioequivalence between your 40 mg-test product given twice (i.e. 80 mg dose) vs 80 mg-reference and if the test product is intended to be given in the same dose as the reference you will not need to provide additional data. I hope this helps. — Kind regards and have a nice day Dr_Dan |
Aga ☆ US, 2017-01-17 12:42 (2628 d 02:10 ago) @ Dr_Dan Posting: # 16964 Views: 3,812 |
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Dear Dr_Dan, You've clarified everything so comprehensively. thank you A LOT. best regards, Aga |