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Pharmacokinetic and Pharmacodynamic Modeling

In: Principles and Practice of Clinical Trials

Author

Listed:
  • Shamir N. Kalaria

    (University of Maryland School of Pharmacy, Center for Translational Medicine)

  • Hechuan Wang

    (University of Maryland School of Pharmacy, Center for Translational Medicine)

  • Jogarao V. Gobburu

    (University of Maryland School of Pharmacy, Center for Translational Medicine)

Abstract

Pharmacokinetic and pharmacodynamic (PKPD) concepts and approaches play a critical role by increasing the efficiency throughout the drug development process and optimizing clinical therapeutics. Innovative quantitative analysis that integrate PKPD and disease progression knowledge are pivotal in regulatory decision-making and have shown to provide supportive evidence of effectiveness. Objective approaches to dose-selection that are informed by exposure-response analyses can assist in visualizing benefit-risk profiles on an individual and population level. Clinical trial simulations using quantitative models that incorporate structural and stochastic components along with prior knowledge can allow for informing clinical trial design features, dose selection in unstudied patient populations, and regulatory policy development. This chapter presents various PKPD-based analyses throughout the drug development process and within precision medicine. Emphasis on the use of PKPD analysis for proof of concept, dose-ranging, and first in human dose studies are subsequently provided. Case studies are highlighted to better illustrate the impact of quantitative analyses for decision-making.

Suggested Citation

  • Shamir N. Kalaria & Hechuan Wang & Jogarao V. Gobburu, 2022. "Pharmacokinetic and Pharmacodynamic Modeling," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 98, pages 1937-1960, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-52636-2_284
    DOI: 10.1007/978-3-319-52636-2_284
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