Dose Finding in Drug Development

  • Naitee Ting

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

Table of contents

  1. Front Matter
    Pages I-XIV
  2. David Salsburg
    Pages 18-29
  3. Anastasia Ivanova
    Pages 49-58
  4. Mourad Tighiouart, André Rogatko
    Pages 59-72
  5. James Macdougall
    Pages 127-145
  6. José C. Pinheiro, Frank Bretz, Michael Branson
    Pages 146-171
  7. Ajit C. Tamhane, Brent R. Logan
    Pages 172-183
  8. Xiang Ling, Jason Hsu, Naitee Ting
    Pages 184-199
  9. Christy Chuang-Stein, Zhengqing Li
    Pages 200-219
  10. Mark Chang, Shein-Chung Chow
    Pages 220-241
  11. Back Matter
    Pages 243-248

About this book

Introduction

When you go to the pharmacy and fill a prescription, have you ever wondered if the dose of the medication is right for you? Can the dose be too low so that the drug will not work? Can the dose be too high that it may cause some potential problem? How do people learn about dosing information? This book answers some of these questions.

Dosing information on the drug label is based on discussion and agreement between the pharmaceutical manufacturer and the drug regulatory agency. A drug label is a high level summary of results obtained from many scientific experiments. Scientists with biological, chemical, medical, or statistical background working in the pharmaceutical industry designed and executed these experiments to obtain information to help understand the dosing information.

This book introduces the drug development process, the design and analysis of clinical trials. Many of the discussions are based on applications of statistical methods in the design and analysis of dose response studies. Although the book is prepared mainly for statisticians/biostatisticians, it also serves as a useful reference to a variety of professionals working for the pharmaceutical industry. The potential readers include pharmacokienticists, clinical scientists, clinical pharmacologists, pharmacists, project managers, pharmaceutical scientists, clinicians, programmers, data managers, regulatory specialists, and study report writers. This book is also a good reference for professionals working in a drug regulatory environment, for example, the FDA. Scientists and/or reviewers from both U.S. and foreign drug regulatory agencies can benefit greatly from this book. In addition, statistical and medical professionals in academia may find this book helpful in understanding the drug development process and practical concerns in selecting doses for a new drug.

Naitee Ting received his Ph. D. in statistics from Colorado State University in 1987 and joined Pfizer Research right after obtaining his Ph. D. Dr. Ting is currently an Associate Director of Biostatistics in Pfizer Global Research and Development, supporting clinical development of new drugs. He has over 18 years of experiences in designing and analyzing late phase clinical trials. During his tenure at Pfizer, Dr. Ting has published more than 20 statistical papers in peer-reviewed journals and book chapters. He has also taught clinical trials courses at the University of Connecticut and University of Rhode Island.

Keywords

Maxima Radiologieinformationssystem clinical trial computerassistierte Detektion development drug drug development pharmaceutical pharmacy research statistics

Editors and affiliations

  • Naitee Ting
    • 1
  1. 1.Pfizer Global Research and DevelopmentNew London

Bibliographic information

  • DOI https://doi.org/10.1007/0-387-33706-7
  • Copyright Information Springer 2006
  • Publisher Name Springer, New York, NY
  • eBook Packages Mathematics and Statistics
  • Print ISBN 978-0-387-29074-4
  • Online ISBN 978-0-387-33706-7
  • Series Print ISSN 1431-8776
  • About this book