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Design and Analysis of Clinical Pharmacology Studies

In: Statistical Methods in Biomarker and Early Clinical Development

Author

Listed:
  • Winnie Weng

    (Gilead Sciences Inc.)

  • Liang Fang

    (MyoKardia Inc.)

Abstract

Clinical pharmacology studies are collections of clinical trials designed to investigate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of a new drug entity. These studies characterize the absorption, distribution, metabolism, and elimination of a drug in human body, and provide critical information for drug labeling. In this chapter, we will introduce different types of clinical pharmacology studies, their PK and safety endpoints, and essential design elements associated with each type of the studies. We will discuss statistical considerations for new study planning, including comparison between various types of designs, as well as power and sample size calculation. We will also discuss commonly used statistical analysis methods, including bioequivalence testing, dose proportionality evaluation, assessment of time-to-steady-state, nonparametric testing of additional PK parameters, and analysis of other safety endpoints. Regulatory guidelines and recommended practice will be reviewed as well.

Suggested Citation

  • Winnie Weng & Liang Fang, 2019. "Design and Analysis of Clinical Pharmacology Studies," Springer Books, in: Liang Fang & Cheng Su (ed.), Statistical Methods in Biomarker and Early Clinical Development, pages 197-220, Springer.
    • Handle: RePEc:spr:sprchp:978-3-030-31503-0_10
    DOI: 10.1007/978-3-030-31503-0_10
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