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Dear All,
Are there any gudelines to study drug interaction
studies(I am interested in metabolic....) in cancer
patients.
How the study differs from the one in Healthy
Volunteers.
Any suggestions on this topic would be highly
appreciated
Regards,
JIM
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Please check Drug Metabolism/Drug Interaction Studies..In Vitro,4/1997
and
In Vivo Drug Metabolism/Drug Interaction Studies-Study Design .....,
11/1999
under Clinical Pharmacology section of the FDA guidance site:
http://www.fda.gov/cder/guidance/index.htm
Hope it is useful.
Best wishes,
Chandra S. Chaurasia
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)