Clinical pharmacokinetic trials using limited sampling design and robust data analysis

  • 橋本 征也 (Principal Investigator)
  • 能澤, 孝 (Co-Investigator(Kenkyū-buntansha))
  • 市田, 蕗子 (Co-Investigator(Kenkyū-buntansha))
  • 田口, 雅登 (Co-Investigator(Kenkyū-buntansha))
  • 石田和也 (Co-Investigator(Kenkyū-buntansha))

Project Details

Abstract

Evaluation of the relationship between pharmacological effect and blood concentration of the drug and investigation of the mechanisms for interindividual variability of the pharmacokinetics of the drug are needed to optimize the drug therapy for patients. Recently, we have clarified that the 3 step analysis is useful method to analyze the limited number of patients and/or data in the exploratory clinical trials. In the present study, we verified whether 3 step data analysis is useful to evaluate the pharmacokinetics of the drug in small or medium scale clinical trials
StatusFinished
Effective start/end date2009/01/012011/12/31

Funding

  • Japan Society for the Promotion of Science: ¥4,550,000.00

Keywords

  • 採血デザイン
  • 臨床薬物動態試験