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Hi,
The final guideline on estimating the maximum safe starting dose in
healthy volunteers has been posted by FDA recently. You can find the
same at the following link...
http://www.fda.gov/cder/guidance/5541fnl.doc
Regards
Ganesh
M.M. Ganesh
Graduate Student
College of Pharmacy
University of Cincinnati, Ohio, USA
Web Page: www.geocities.com/ganaish/gans
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