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Dose-Finding and Dose-Ranging Studies

In: Principles and Practice of Clinical Trials

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  • Mark R. Conaway

    (University of Virginia Health System)

  • Gina R. Petroni

    (University of Virginia Health System, Translational Research and Applied Statistics, Public Health Sciences)

Abstract

There is a growing recognition of the importance of well-designed dose-finding studies in the overall development process. This chapter is an overview of designs for studies that are meant to identifying one or more doses of an agent to be tested in subsequent stages of the drug development process. The chapter also provides a summary of dose-finding designs that have been developed to meet the challenges of contemporary dose-finding trials, including the use of combinations of agents, more complex outcome measures, and heterogeneous groups of participants.

Suggested Citation

  • Mark R. Conaway & Gina R. Petroni, 2022. "Dose-Finding and Dose-Ranging Studies," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 53, pages 951-971, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-52636-2_77
    DOI: 10.1007/978-3-319-52636-2_77
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