PharmPK Discussion - FDA guidance on Human Radiolabeled Study

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On 13 Oct 2006 at 13:30:30, Girish Gupte (girish_gupte2000.aaa.yahoo.com) sent the message


Hello All:
Is there an FDA guidance available on conducting radiolabeled ADME
studies in humans? Can someone please post a link to it, if available?
Thanks
Girish

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On 15 Oct 2006 at 18:07:29, "Beumer, Jan H" (beumerjh.-at-.upmc.edu) sent the message


Dear Girish,

There is some guidance in the code of federal regulations, there is
no FDA guideline. I hope you will find the following review to be
helpful. Contact me directly if you would like a reprint.

Jan

1: Clin Pharmacokinet. 2006;45(1):33-58.

Mass balance studies, with a focus on anticancer drugs.

Beumer JH, Beijnen JH, Schellens JH.

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