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

KAKEN

About This Project

Japan Grant Number
JP20790130 (JGN)
Funding Program
Grants-in-Aid for Scientific Research
Funding Organization
Japan Society for the Promotion of Science

Kakenhi Information

Project/Area Number
20790130
Research Category
Grant-in-Aid for Young Scientists (B)
Allocation Type
  • Single-year Grants
Review Section / Research Field
  • Biological Sciences > Medicine, Dentistry, and Pharmacy > Pharmacy > Medical pharmacy
Research Institution
  • University of Toyama
Project Period (FY)
2008 〜 2009
Project Status
Completed
Budget Amount*help
4,290,000 Yen (Direct Cost: 3,300,000 Yen Indirect Cost: 990,000 Yen)

Research Abstract

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.

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