Back to the Top
The following message was posted to: PharmPK
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?
La tua casella email ti va stretta?
Prova Infinito XmaiL: 60MB di spazio
e 10MB di allegati a solo 1 Euro al mese!
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (firstname.lastname@example.org)