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
    2. Perceval Sondag, Pierre Lebrun, Eric Rozet, Bruno Boulanger
      Pages 415-432
    3. Timothy Schofield
      Pages 433-460
    4. Helen Strickland, Stan Altan
      Pages 501-531
    5. Richard K. Burdick, Frank Ye
      Pages 533-548
    6. Stan Altan, Lynne Hare, Helen Strickland
      Pages 549-573
    7. Walter W. Stroup, Michelle Quinlan
      Pages 575-604
    8. Buffy Hudson-Curtis, Steven Novick
      Pages 631-651
    9. Wen Wu, Athula Herath
      Pages 653-673
    10. Jason J. Z. Liao
      Pages 675-694
  6. Back Matter
    Pages 695-698

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