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Registersubmission to two countries [Regulatives / Guidelines]
Dear All,
Can a Bioequivalence study planned as a three way cross over study i.e. one test and two refrence formulations be submitted to two different countries. One of the reference formulations will be from UK and the study will be for submission to MHRA and the the other reference formulation shall be from USA and will be for submission to USFDA. The protocol shall be designed based on guidelines of both the countries. So now can this study be submitted to both UK MHRA and USFDA since this study is conducted based on the guidences of both the countries and reference IPs have been procured from both the countries?
Thanks and regards
P.S.Srinivas
Can a Bioequivalence study planned as a three way cross over study i.e. one test and two refrence formulations be submitted to two different countries. One of the reference formulations will be from UK and the study will be for submission to MHRA and the the other reference formulation shall be from USA and will be for submission to USFDA. The protocol shall be designed based on guidelines of both the countries. So now can this study be submitted to both UK MHRA and USFDA since this study is conducted based on the guidences of both the countries and reference IPs have been procured from both the countries?
Thanks and regards
P.S.Srinivas
Complete thread:
- submission to two countriessarada06884 2013-07-06 11:10
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- submission to two countries ElMaestro 2013-07-06 11:54
- submission to two countries drgunasakaran1 2013-07-07 08:03
Ing. Helmut Schütz