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kishor ☆ 2010-08-19 10:41 (5380 d 14:57 ago) Posting: # 5805 Views: 5,672 |
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Dear all, Can any body tell me about-Is there any study for reference product BE means reference vs reference product BE study? Is there any BE data for Reference product vs reference product? Regards kishor Edit: Subject changed. [Helmut] |
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janmacek ☆ Czech Republic, 2010-08-27 11:20 (5372 d 14:18 ago) @ kishor Posting: # 5848 Views: 4,461 |
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Dear Kishor, you can look to data from a study with replicated cross-over design where the reference product was administered twice. These studies can be used to estimate intra-subject variability. Of course, the ratio reference (administration 1) / reference (administration 2) should converge to 100% with increasing number of subjects. With kind regards, Jan |
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Cmax ☆ India, 2010-08-27 21:50 (5372 d 03:48 ago) @ kishor Posting: # 5860 Views: 4,446 |
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Hi Kishore, why you need to comapre a ref with a ref... without test... instead of that you can compare your product with ref... |
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patilatu ☆ 2010-09-22 07:58 (5346 d 17:40 ago) @ Cmax Posting: # 5928 Views: 4,228 |
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❝ why you need to comapre a ref with a ref... without test... instead of that you can compare your product with ref... Dear Kishor, You take any country, there would be only one reference product, i.e. innovator's product, which has already been proven to the best one. So I dont think that there is any need to do this. |
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Dr_Dan ★★ Germany, 2010-09-22 11:34 (5346 d 14:04 ago) @ kishor Posting: # 5930 Views: 4,256 |
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Dear all For a generic product the marketing authorisation applications reference must be made to the dossier of a reference medicinal product for which a marketing authorisation is or has been granted on the basis of a complete dossier. In other words: The reference product is always the innovator product. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz