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Dose-Finding Studies in Phase I and Estimation of Maximally Tolerated Dose

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Dose Finding in Drug Development

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

Abstract

Historically, drugs have been marketed at excessive doses (i.e., doses well onto the plateau of the efficacy dose–response relationship) with some patients experiencing adverse events (AEs) unnecessarily (Herxheimer, 1991; ICH-E4, 1994). Over the last 5 years, a greater effort has been made to ensure that the best benefit to risk assessment is obtained for each new drug (Andrews and Dombeck, 2004; Bush et al., 2005). The benefit to risk assessment of marketed drugs has been improved, in some cases, by postmarketing label changes, which aim to optimize the dosage regimen for the indicated populations (Cross et al., 2002). These postmarketing changes in the label may reflect the quality of drug development, regulatory review and postmarketing surveillance.

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Authors
  1. Marlene Modi
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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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Modi, M. (2006). Dose-Finding Studies in Phase I and Estimation of Maximally Tolerated Dose. 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_3

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