Studies - Typical Designs

Christopher Marshallsay Axel Steinstraesser Roland Wesch 

Impact of Gender, High Age, and Food Intake, on Drug Disposition 666 

4 Profiling of Drug Absorption, Distribution, Metabolism and Elimination in Man  

Drug efficacy and response is a function of drug concentration over time. In clinical pharmacokinetic studies, aspects of drug absorption, distribution, metabolism, and excretion over time are assessed. In the early clinical development the pharmacokinetics of a drug is studied in healthy subjects followed by studies in patient population(s) with the aim to find the relevant dose in the target population(s). Particular pharmacokinetic studies in special populations assess the necessity of a dose adjustment from the planned/established clinical dose for patients. 

In the following sections, typical clinical pharmacokinetic studies are presented with results and conclusions, along with special emphasis on the individual study rational, objective, design, and evaluation technique. In addition, a critical assessment of the method, as well as potential modifications and alternatives are presented. 

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