Study Population

The ADME study is usually performed in healthy, adult, male volunteers, 18-45 years of age. Women are traditionally excluded due to the potential risks associated by exposing females of childbearing potential to a yet unapproved, radiolabeled drug. By the same token, certain investigators limit the lower age limits of the male volunteers to an age arbitrarily chosen above 18, for example an age of 35 years, and may extend the upper age limit to 60 years. The number of subjects is usually low (n=4-8), but some caution should be used in keeping the number of subjects high enough, so that the results will be informative. If the drug has shown highly variable pharmacokinetics in earlier studies, a larger number of subjects may have to be included in the study.

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