Back to the Top
Dear Members,
In regulatory point of view is it mandatory to provide batch details
of the drug products to be used in study protocol for BA/BE studies.
regards,
Kiran Kumar
Back to the Top
The following message was posted to: PharmPK
Dear Kiran,
It is not mandatory to give the batch details in your protocol, which is
not possible in most cases and which is also justifiable, as the sponsor
cannot send the samples before getting the approval of IEC.
But if your sponsor is ready with the IPs, you can get the batch details
and can incorporate the same in your protocol. Otherwise it is fine if
you don't mention the same in the protocol.
Hope I have given some useful information. Inputs from other members
will be appreciated.
Regards,
Dr. M. Joseph
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)