Study Population

As described elsewhere in this chapter, the study population of choice is usually healthy, adult male and female volunteers, above 18 years of age. The pharmacokinetics of the drug after repeated dosing should also be studied in the intended target patient population, and compared to that of the healthy volunteers. However, the comparison of the steady-state pharmacokinetics of the drug between healthy volunteers and patients can be made across studies, and a direct comparison in the same study is not necessary.

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