Dose Finding in Drug Development

Editors:

ISBN: 978-0-387-29074-4 (Print) 978-0-387-33706-7 (Online)

Table of contents (14 chapters)

  1. Front Matter

    Pages I-XIV

  2. No Access

    Book Chapter

    Pages 1-17

    Introduction and New Drug Development Process

  3. No Access

    Book Chapter

    Pages 18-29

    Dose Finding Based on Preclinical Studies

  4. No Access

    Book Chapter

    Pages 30-48

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

  5. No Access

    Book Chapter

    Pages 49-58

    Dose-Finding in Oncology—Nonparametric Methods

  6. No Access

    Book Chapter

    Pages 59-72

    Dose Finding in Oncology—Parametric Methods

  7. No Access

    Book Chapter

    Pages 73-88

    Dose Response: Pharmacokinetic–Pharmacodynamic Approach

  8. No Access

    Book Chapter

    Pages 89-105

    General Considerations in Dose–Response Study Designs

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    Book Chapter

    Pages 106-126

    Clinical Trial Simulation—A Case Study Incorporating Efficacy and Tolerability Dose Response

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    Book Chapter

    Pages 127-145

    Analysis of Dose–Response Studies—Emax Model

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    Book Chapter

    Pages 146-171

    Analysis of Dose–Response Studies—Modeling Approaches

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    Book Chapter

    Pages 172-183

    Multiple Comparison Procedures in Dose Response Studies

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    Book Chapter

    Pages 184-199

    Partitioning Tests in Dose–Response Studies with Binary Outcomes

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    Book Chapter

    Pages 200-219

    Analysis of Dose–Response Relationship Based on Categorical Outcomes

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    Book Chapter

    Pages 220-241

    Power and Sample Size for Dose Response Studies

  16. Back Matter

    Pages 243-248