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aanrin ☆ United Arab Emirates, 2016-03-07 09:36 (3760 d 20:01 ago) (edited on 2016-03-07 10:52) Posting: # 16062 Views: 4,990 |
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Dear Helmut In order to conduct a BE study for naproxen 220mg there is no competitor in the market with the same strength. please advise whether we can do the study with the strength 200mg for the comparator. or else what is the regulation in general for this kind of situation when we introduce a new strength. With regards |
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Dr_Dan ★★ Germany, 2016-03-07 14:12 (3760 d 15:25 ago) @ aanrin Posting: # 16066 Views: 3,927 |
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Dear aanrin What would be the reason for conducting a BE study of naproxen 220mg against the competitor strength of 200mg? Both formulation should not be bioequivalent, right? A medicinal product is therapeutically equivalent with another product if it contains the same active substance or therapeutic moiety and, clinically, shows the same efficacy and safety as that product, whose efficacy and safety has been established. In practice, demonstration of bioequivalence is generally the most appropriate method of substantiating therapeutic equivalence. Your product is not therapeutically equivalent and therefore you will need data for safety and efficacy of your own formulation (strength). So you are obliged to conduct at least one phase III study. I hope this helps. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz