PharmPK Discussion - Bioequivalence EU/FDA

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On 31 Jul 2003 at 16:58:44, (padonda.-a-.infinito.it) sent the message


The following message was posted to: PharmPK

Dear all,
I'm currently planning a bioequivalence study for a generic drug. As I
know guidelines of EU (EMEA) and FDA require similar, but not
identical, condition to be matched. Are you familiar with possible
planning of a single BE study fulfilling both FDA and EU requirements
to submit the identical results to both regulatory authorities? Have
you references (review, etc.) spiking about possible simultaneous BE
study submission to FDA and EMEA?
Best Regards
Palmiro
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