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Pharmacokinetic and Pharmacodynamic Modeling

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Principles and Practice of Clinical Trials

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.

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Author information

Authors and Affiliations

  1. Center for Translational Medicine, University of Maryland School of Pharmacy, Baltimore, MD, USA

    Shamir N. Kalaria, Hechuan Wang & Jogarao V. Gobburu

Authors
  1. Shamir N. Kalaria
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  2. Hechuan Wang
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  3. Jogarao V. Gobburu
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Corresponding author

Correspondence to Jogarao V. Gobburu .

Editor information

Editors and Affiliations

  1. Samuel Oschin Comprehensive Cancer Insti, WEST HOLLYWOOD, CA, USA

    Steven Piantadosi

  2. Bloomberg School of Public Health, Johns Hopkins Center for Clinical Trials Bloomberg School of Public Health, Baltimore, MD, USA

    Curtis L. Meinert

Section Editor information

  1. Dept. of Biostatistics and Bioinformatics,Basic Science Divison, Duke University, School of Medicine, Durham, North Carolina, USA

    Stephen George

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Kalaria, S.N., Wang, H., Gobburu, J.V. (2020). Pharmacokinetic and Pharmacodynamic Modeling. In: Piantadosi, S., Meinert, C. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52677-5_284-1

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  • DOI: https://doi.org/10.1007/978-3-319-52677-5_284-1

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-52677-5

  • Online ISBN: 978-3-319-52677-5

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