PharmPK Discussion - Mass balance in non rodents for US IND

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On 25 Feb 2005 at 15:37:12, patilv.at.wockhardtin.com sent the message


Dear all,

1) I want to know that before filing IND application in United States -
Are
we supposed to conduct full ADME in rats and mass balance in non rodents
using 14C labeled compound.

2) Are we supposed to do 14C labeled studies using primary hepatocytes.

I am trying to get this information from CDER web site but I am not
able to
get a correct link.

Vinod Patil.
Wockhardt Research Center,
Aurangabad(India)

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