Precision and accuracy of clinical repeated-dose pharmacokinetic trials applying a peak-and-trough sampling design to estimate oral clearance

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The area under the concentration-time curve (AUC) and/or oral clearance (CL/F) of drugs is a key pharmacokinetic parameter to evaluate drug exposure in patients. In the present study, we performed a simulation for the clinical pharmacokinetic study, in which blood was sampled at two time points corresponding to the peak concentration (C_<peak>) and trough concentration (C_<trough>) following repetitive oral drug administration to subjects. The approximate oral clearance (CL/F_<approx>) and/or an alternative oral clearance (CL/F_<exp>) were accurate for hypothetical drugs with varied pharmacokinetic properties. We performed that the peak-and-trough sampling design is promising for the clinical repeated-dose pharmacokinetic trial for drugs.