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RegisterOne study, two generics [Regulatives / Guidelines]
posted by Clarc 
– Romania, 2013-11-18 09:27 (4608 d 07:00 ago) – Posting: # 11903
Views: 2,914
Dear all
One of our sponsors requested a bioequivalence trial performed in such way, that the results (final report) could be used in two different countries, by two different companies, under two different names. The test product is the same product, produced by one of the two companies, however they want to authorize it separately.
Is this possible? And if the answer is yes, please enlighten me how?
Thanks.
Clarc
One of our sponsors requested a bioequivalence trial performed in such way, that the results (final report) could be used in two different countries, by two different companies, under two different names. The test product is the same product, produced by one of the two companies, however they want to authorize it separately.
Is this possible? And if the answer is yes, please enlighten me how?
Thanks.
Clarc
—
I'm always tryin' to do something new, tryin' to look like a beginner.
Meshell Ndegeocello
I'm always tryin' to do something new, tryin' to look like a beginner.
Meshell Ndegeocello
Complete thread:
- One study, two genericsClarc 2013-11-18 08:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- One study, two generics Dr_Dan 2013-11-18 11:17
- One study, two generics Clarc 2013-11-19 10:19
- One study, two generics Dr_Dan 2013-11-18 11:17
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