Bioequivalence and Bioavailability Forum • submission to two countries

sarada06884
☆

India,
2013-07-06 13:10
(4736 d 09:01 ago)

Posting: # 10951
Views: 3,004

submission 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

ElMaestro
★★★

Denmark,
2013-07-06 13:54
(4736 d 08:17 ago)

@ sarada06884
Posting: # 10952
Views: 2,462

submission to two countries

Post reply

Hello PSS,

❝ 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 (...) 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?

Plain and simply: Yes.

—
Pass or fail!
ElMaestro

drgunasakaran1
★★

2013-07-07 10:03
(4735 d 12:08 ago)

@ sarada06884
Posting: # 10957
Views: 2,427

submission to two countries

Post reply

Dear Mr P S Srinivas,

EMA's Guideline on the Investigation of Bioequivalence, Doc. Ref.: CPMP/EWP/QWP/1401/98 Rev. 1, states that "In studies with more than two treatment arms (e.g. a three period study including two references, one from EU and another from USA, or a four period study including test and reference in fed and fasted states), the analysis for each comparison should be conducted excluding the data from the treatments that are not relevant for the comparison in question".

Hence, you can conduct three way cross over study with one test and two reference formulations to be submitted to two different countries.

—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn