Nonclinical Statistics for Pharmaceutical and Biotechnology Industries

Part I. Introduction

1. Introduction to Nonclinical Statistics for Pharmaceutical and Biotechnology Industries
Lanju Zhang, Cheng Su

2. Regulatory Nonclinical Statistics
Mohammad Atiar Rahman, Meiyu Shen, Xiaoyu (Cassie) Dong, Karl K. Lin, Yi Tsong

3. How To Be a Good Nonclinical Statistician
Bill Pikounis, Luc Bijnens

Part II. Statistical Methods for Drug Discovery

4. Statistical Methods for Drug Discovery
Max Kuhn, Phillip Yates, Craig Hyde

5. High-Throughput Screening Data Analysis
Hanspeter Gubler

6. Quantitative-Structure Activity Relationship Modeling and Cheminformatics
Max Kuhn

7. GWAS for Drug Discovery
Yang Lu, Katherine Perez-Morera, Rita M. Cantor

8. Statistical Applications in Design and Analysis of In Vitro Safety Screening Assays
Lei Shu, Gary Gintant, Lanju Zhang

Part III. Statistical Methods for Nonclinical Development

9. Nonclinical Safety Assessment: An Introduction for Statisticians
Ian S. Peers, Marie C. South

10. General Toxicology, Safety Pharmacology, Reproductive Toxicology, and Juvenile Toxicology Studies
Steven A. Bailey, Dingzhou Li, David M. Potter

11. Clinical Assays for Biological Macromolecules
Jianchun Zhang, Robert J. Kubiak

12. Recent Research Projects by the FDA’s Pharmacology and Toxicology Statistics Team
Karl K. Lin, Matthew T. Jackson, Min Min, Mohammad Atiar Rahman, Steven F. Thomson

13. Design and Evaluation of Drug Combination Studies
Lanju Zhang, Hyuna Yang

14. Biomarkers
Chris Harbron

Part IV. Statistical Methods for CMC

15. Overview of Drug Development and Statistical Tools for Manufacturing and Testing
John Peterson, Stan Altan

16. Assay Validation
Perceval Sondag, Pierre Lebrun, Eric Rozet, Bruno Boulanger

17. Lifecycle Approach to Bioassay
Timothy Schofield

18. Quality by Design: Building Quality into Products and Processes
Ronald D. Snee

19. Process Validation in the Twenty-First Century
Helen Strickland, Stan Altan

20. Acceptance Sampling
Richard K. Burdick, Frank Ye

21. Process Capability and Statistical Process Control
Stan Altan, Lynne Hare, Helen Strickland

22. Statistical Considerations for Stability and the Estimation of Shelf Life
Walter W. Stroup, Michelle Quinlan

23. In Vitro Dissolution Testing: Statistical Approaches and Issues
David LeBlond

24. Assessing Content Uniformity
Buffy Hudson-Curtis, Steven Novick

25. Chemometrics and Predictive Modelling
Wen Wu, Athula Herath

26. Statistical Methods for Comparability Studies
Jason J. Z. Liao

Nyckelord: Statistics, Statistics for Life Sciences, Medicine, Health Sciences, Medicine/Public Health, general, Pharmacology/Toxicology