Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review

  • Zhao P
  • Zhang L
  • Grillo J
 et al. 
  • 159

    Readers

    Mendeley users who have this article in their library.
  • 251

    Citations

    Citations of this article.

Abstract

Physiologically based pharmacokinetic (PBPK) modeling and simulation is a tool that can help predict the pharmacokinetics of drugs in humans and evaluate the effects of intrinsic (e.g., organ dysfunction, age, genetics) and extrinsic (e.g., drug-drug interactions) factors, alone or in combinations, on drug exposure. The use of this tool is increasing at all stages of the drug development process. This report reviews recent instances of the use of PBPK in decision-making during regulatory review. The examples are based on Center for Drug Evaluation and Research reviews of several submissions for investigational new drugs (INDs) and new drug applications (NDAs) received between July 2008 and June 2010. The use of PBPK modeling and simulation facilitated the following types of decisions: the need to conduct specific clinical pharmacology studies, specific study designs, and appropriate labeling language. The report also discusses the challenges encountered when PBPK modeling and simulation were used in these cases and recommends approaches to facilitating full utilization of this tool.

Get free article suggestions today

Mendeley saves you time finding and organizing research

Sign up here
Already have an account ?Sign in

Find this document

Authors

  • P. Zhao

  • L. Zhang

  • J. A. Grillo

  • Q. Liu

  • J. M. Bullock

  • Y. J. Moon

Cite this document

Choose a citation style from the tabs below

Save time finding and organizing research with Mendeley

Sign up for free