© 2016

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

About the editors

Lanju Zhang is Director in Statistics and Head of Nonclinical Statistics Group in the department of Data and Statistical Sciences at AbbVie. He leads a group providing statistical support to preclinical studies and CMC areas. Prior to moving to AbbVie, he was in MedImmune with increasing responsibilities to support all nonclinical areas. He is active in research and has published many papers and book chapters in nonclinical and clinical areas. He received his PhD in Statistics in 2005 from University of Maryland Baltimore County.

Max Kuhn is a Senior Director in Research Statistics in Pfizer R&D in Groton CT. He has over 15 years of experience in the pharmaceutical and diagnostic industries. His interests are in the application of machine learning models and estimation problems in general. He is the co-author of the best selling text Applied Predictive Modeling and the author of eight R packages.

Ian Peers is a senior Leader in Global Medicines Development at AstraZeneca. He received his BSc from the University of Wales, Bangor and his Masters and Ph.D degrees from the University of Manchester.  He has  over 26 years experience working as an academic and industrial Statistician in Research and Development with 14 years experience in Biopharmaceuticals research including 11 years as  Global Head of Statistics at AstraZeneca.  Ian has collaborated with academic researchers globally, has supervised doctoral and postdoctoral students, worked in several therapeutic areas  and has published and presented on pre-clinical, translational and clinical research.  Ian is a professional Charted Statistician (CStat)of the Royal Statistical Society and holds an Honorary Professorship in the Faculty of Natural Sciences at the University of Stirling.

Stan Altan is Senior Director and Research Fellow of Nonclinical Statistics at Janssen Research & Development, LLC . Stan received his Ph.D. from Temple University in Biometrics. Stan is a Fellow of the American Statistical Association. Over the past 30+ years, Stan has supported drug discovery, toxicology, pharmaceutical and chemical development, biologics, and all Phases of clinical studies. Stan is a founding member of the Nonclinical Biostatistics Leaders’ Forum, the IQ Consortium Statistical Leadership Group and the AAPS CMC Statistics Focus Group. Stan is on the editorial board of the Statistics in Biopharmaceutical Research journal, an ASA publication.

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