© 2019

Statistical Methods in Biomarker and Early Clinical Development

  • Liang Fang
  • Cheng Su

Table of contents

  1. Front Matter
    Pages i-xii
  2. M. Man, T. S. Nguyen, C. Battioui, G. Mi
    Pages 1-22
  3. G. Mi, W. Li, T. S. Nguyen
    Pages 23-38
  4. Yongming Qu
    Pages 39-52
  5. Jing Wang, Mark Chang
    Pages 53-65
  6. Guang Chen, Shuguang Huang, Winnie Weng, Cheng Su
    Pages 87-115
  7. Yoonha Choi, Jing Huang
    Pages 117-136
  8. Jing Lu, Yangyang Hao, Jing Huang, Su Yeon Kim
    Pages 167-195
  9. Winnie Weng, Liang Fang
    Pages 197-220
  10. Laurence Colin, Brian Smith
    Pages 221-245
  11. Laurence Colin, Brian Smith
    Pages 247-274
  12. Liang Fang, Winnie Weng, Lu Wang, Xiaoru Wu
    Pages 275-299
  13. Qiqi Deng, Naitee Ting
    Pages 301-320
  14. Alan H. Hartford, Kenneth G. Kowalski
    Pages 321-348

About this book


This contributed volume offers a much-needed overview of the statistical methods in early clinical drug and biomarker development. Chapters are written by expert statisticians with extensive experience in the pharmaceutical industry and regulatory agencies. Because of this, the data presented is often accompanied by real world case studies, which will help make examples more tangible for readers. The many applications of statistics in drug development are covered in detail, making this volume a must-have reference.

Biomarker development and early clinical development are the two critical areas on which the book focuses. By having the two sections of the book dedicated to each of these topics, readers will have a more complete understanding of how applying statistical methods to early drug development can help identify the right drug for the right patient at the right dose. Also presented are exciting applications of machine learning and statistical modeling, along with innovative methods and state-of-the-art advances, making this a timely and practical resource.

This volume is ideal for statisticians, researchers, and professionals interested in pharmaceutical research and development. Readers should be familiar with the fundamentals of statistics and clinical trials.


Biomarkers Biomarker testing Biomarker Development Biomarker data Biomarker book Early clinical development Predictive biomarker Drug development statistics Biostatistics Personalized Medicine Precision Medicine Translational Medicine Clinical Trials Pharmaceutical Development Machine learning medicine Clinical pharmacology Clinical pharmacology in drug development Pharmacodynamics

Editors and affiliations

  • Liang Fang
    • 1
  • Cheng Su
    • 2
  1. 1.MyoKardia Inc.South San FranciscoUSA
  2. 2.BioMarin Pharmaceutical Inc.San RafaelUSA

About the editors

​Liang Fang is an Executive Director and Head of Biostatistics in MyoKardia Inc. His research interests include statistical applications in drug development, precision medicine, and digital health.

Cheng Su is an Executive Director of Data Science & Analytics at BioMarin, Inc. His research interests include statistical applications and tool development in drug discovery, biomarkers, clinical trials design, risk based monitoring, mobile health and big data.

Bibliographic information

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