Nonclinical Statistics for Pharmaceutical and Biotechnology Industries

  • Lanju Zhang

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

Table of contents

  1. Front Matter
    Pages i-xxii
  2. Introduction

    1. Front Matter
      Pages 1-1
    2. Mohammad Atiar Rahman, Meiyu Shen, Xiaoyu (Cassie) Dong, Karl K. Lin, Yi Tsong
      Pages 19-31
    3. Bill Pikounis, Luc Bijnens
      Pages 33-50
  3. Statistical Methods for Drug Discovery

    1. Front Matter
      Pages 51-51
    2. Max Kuhn, Phillip Yates, Craig Hyde
      Pages 53-81
    3. Hanspeter Gubler
      Pages 83-139
    4. Yang Lu, Katherine Perez-Morera, Rita M. Cantor
      Pages 157-176
  4. Statistical Methods for Nonclinical Development

    1. Front Matter
      Pages 199-199
    2. Ian S. Peers, Marie C. South
      Pages 201-230
    3. Jianchun Zhang, Robert J. Kubiak
      Pages 263-294
    4. Karl K. Lin, Matthew T. Jackson, Min Min, Mohammad Atiar Rahman, Steven F. Thomson
      Pages 295-348
    5. Lanju Zhang, Hyuna Yang
      Pages 349-363
    6. Chris Harbron
      Pages 365-380
  5. Statistical Methods for CMC

    1. Front Matter
      Pages 381-381

About this book


This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions.


Animal studies Biomarker Chemistry, manufacturing and controls (CMC) Drug research and development Nonclinical statistics

Editors and affiliations

  • Lanju Zhang
    • 1
  1. 1.Nonclinical Statistics, Abbvie IncNorth ChicagoUSA

Bibliographic information

  • DOI
  • Copyright Information Springer International Publishing Switzerland 2016
  • Publisher Name Springer, Cham
  • eBook Packages Mathematics and Statistics
  • Print ISBN 978-3-319-23557-8
  • Online ISBN 978-3-319-23558-5
  • Series Print ISSN 1431-8776
  • Series Online ISSN 2197-5671
  • About this book