Advertisement

Quantitative Decisions in Drug Development

  • Christy Chuang-Stein
  • Simon Kirby
Book

Part of the Springer Series in Pharmaceutical Statistics book series (SSPS)

Table of contents

  1. Front Matter
    Pages i-xv
  2. Christy Chuang-Stein, Simon Kirby
    Pages 1-18
  3. Christy Chuang-Stein, Simon Kirby
    Pages 19-31
  4. Christy Chuang-Stein, Simon Kirby
    Pages 33-40
  5. Christy Chuang-Stein, Simon Kirby
    Pages 41-51
  6. Christy Chuang-Stein, Simon Kirby
    Pages 53-67
  7. Christy Chuang-Stein, Simon Kirby
    Pages 69-84
  8. Christy Chuang-Stein, Simon Kirby
    Pages 85-104
  9. Christy Chuang-Stein, Simon Kirby
    Pages 105-121
  10. Christy Chuang-Stein, Simon Kirby
    Pages 123-137
  11. Christy Chuang-Stein, Simon Kirby
    Pages 139-151
  12. Christy Chuang-Stein, Simon Kirby
    Pages 173-190
  13. Christy Chuang-Stein, Simon Kirby
    Pages 191-207
  14. Back Matter
    Pages 209-248

About this book

Introduction

This book offers a high-level treatise of evidence-based decisions in drug development. Because of the inseparable relationship between designs and decisions, a good portion of this book is devoted to the design of clinical trials. The book begins with an overview of product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and decision making at different stages of drug development. The latter include selecting appropriate metrics to formulate decisions criteria, determining go/no-go decisions for progressing a drug candidate to the next stage and predicting the effectiveness of a product. Lastly, it points out common mistakes made by drug developers under the current drug-development paradigm.

The book offers useful insights to statisticians, clinicians, regulatory affairs managers and decision-makers in the pharmaceutical industry who have a basic understanding of the drug-development process and the clinical trials conducted to support drug-marketing authorization.

The authors provide software codes for select analytical approaches discussed in the book. The book includes enough technical details to allow statisticians to replicate the quantitative illustrations so that they can generate information to facilitate decision-making themselves.

Keywords

clinical trials metric for decision drug development probability of study success probability of product success go/no go criteria evidence-based decision regulatory affairs

Authors and affiliations

  • Christy Chuang-Stein
    • 1
  • Simon Kirby
    • 2
  1. 1.KalamazooUSA
  2. 2.Pfizer Statistical Research & Consulting CenterCambridgeUnited Kingdom

Bibliographic information

  • DOI https://doi.org/10.1007/978-3-319-46076-5
  • Copyright Information Springer International Publishing AG 2017
  • Publisher Name Springer, Cham
  • eBook Packages Mathematics and Statistics
  • Print ISBN 978-3-319-46075-8
  • Online ISBN 978-3-319-46076-5
  • Series Print ISSN 2366-8695
  • Series Online ISSN 2366-8709
  • Buy this book on publisher's site