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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
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
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Single Bio for EU and US bharathi 2011-11-14 06:50
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Single Bio for EU and USDr_Dan 2011-11-14 09:43
- Single Bio for EU and US msmnainar 2011-11-14 12:02
- Single Bio for EU and US Helmut 2011-11-14 13:43
- Single Bio for EU and US bharathi 2011-11-15 05:09
- Single Bio for EU and US Helmut 2011-11-14 13:43
Ing. Helmut Schütz