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bharathi ☆ India, 2011-11-14 07:50 (5343 d 06:58 ago) (edited on 2011-11-15 05:12) Posting: # 7662 Views: 3,654 |
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Dear All, Please can anyone here help me out to answer- We are planning to launch our product in both US and EU countries. Innovator for both US and EU is the same (even manufacturing site being the same). Can we perform Bio with any one of the Product (US/EU), and confirm that it holds good for the both. Thanks in advance |
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Dr_Dan ★★ Germany, 2011-11-14 10:43 (5343 d 04:05 ago) @ bharathi Posting: # 7663 Views: 3,188 |
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Dear bharathi If you can prove that the innovator product for both US and EU is the same you can go along with one study. But how to prove? Maybe you can ask the innovator to issue a written confirmation.  We always have the same problem. There are strong indications and it would be logical that innovator product for both US and EU is the same but we can not prove this and consequently we have to perform two studies. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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msmnainar ★ India, 2011-11-14 13:02 (5343 d 01:46 ago) @ bharathi Posting: # 7664 Views: 3,090 |
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Hi Bharathi Else you can do three way study using two references to establish BE. Kind regards Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] — Sundar. M |
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Helmut ★★★   Vienna, Austria, 2011-11-14 14:43 (5343 d 00:05 ago) @ msmnainar Posting: # 7668 Views: 3,078 |
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Dear Sundar! ❝ Else you can do three way study using two references to establish BE. Correct. But see EMA’s GL (Section 4.1.8): In studies with more than two treatment arms (e.g. a three period study including two references, one from EU and another from USA […]), the analysis for each comparison should be conducted excluding the data from the treatments that are not relevant for the comparison in question. It’s not clear whether this ‘method’ keeps the patient’s risk at 5 % (see this rather lengthy thread).BTW, what if the test is BE to one reference and not the other? I expect that the FDA wants to see the analysis of the full model. Questions approaching. Besides FDA’s and EMA’s BE rules are not the same – only similar (e.g., study population, fed/fasting, scaling, …). I would also go with Dan’s suggestion and perform two studies. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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bharathi ☆ India, 2011-11-15 06:09 (5342 d 08:39 ago) @ Helmut Posting: # 7673 Views: 3,053 |
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Thanks a lot! So the conclusion is we can't avoid duplication of study... (Inspite knowing that it is duplication). |
Ing. Helmut Schütz