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Dose Response: Pharmacokinetic–Pharmacodynamic Approach

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Dose Finding in Drug Development

Part of the book series: Statistics for Biology and Health ((SBH))

Abstract

Almost all clinical trials include responses measured over time. It is valuable to understand how these responses arise as a function of treatment dose and time. It is particularly important in planning and interpreting Phase IIB (“dose response”) and Phase III (“confirmation of effectiveness”) trials. This chapter describes how the dose–response relationship can be understood in pharmacological terms. It reviews the basic principles of clinical pharmacology (pharmacokinetics, pharmacodynamics, and disease progress) and shows how they can be used to describe the time course of response both with and without drug.

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Authors
  1. Nick Holford
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Editors and Affiliations

  1. Pfizer Global Research and Development, New London, CT, 06320

    Naitee Ting

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© 2006 Springer

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Holford, N. (2006). Dose Response: Pharmacokinetic–Pharmacodynamic Approach. In: Ting, N. (eds) Dose Finding in Drug Development. Statistics for Biology and Health. Springer, New York, NY. https://doi.org/10.1007/0-387-33706-7_6

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