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

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_) and trough concentration (C_) following repetitive oral drug administration to subjects. The approximate oral clearance (CL/F_) and/or an alternative oral clearance (CL/F_) 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.