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.
Author(s): Lanju Zhang (eds.)
Series: Statistics for Biology and Health
Edition: 1
Publisher: Springer International Publishing
Year: 2016
Language: English
Pages: XXII, 698
Tags: Statistics for Life Sciences, Medicine, Health Sciences; Medicine/Public Health, general; Pharmacology/Toxicology
Front Matter....Pages i-xxii
Front Matter....Pages 1-1
Introduction to Nonclinical Statistics for Pharmaceutical and Biotechnology Industries....Pages 3-17
Regulatory Nonclinical Statistics....Pages 19-31
How To Be a Good Nonclinical Statistician....Pages 33-50
Front Matter....Pages 51-51
Statistical Methods for Drug Discovery....Pages 53-81
High-Throughput Screening Data Analysis....Pages 83-139
Quantitative-Structure Activity Relationship Modeling and Cheminformatics....Pages 141-155
GWAS for Drug Discovery....Pages 157-176
Statistical Applications in Design and Analysis of In Vitro Safety Screening Assays....Pages 177-198
Front Matter....Pages 199-199
Nonclinical Safety Assessment: An Introduction for Statisticians....Pages 201-230
General Toxicology, Safety Pharmacology, Reproductive Toxicology, and Juvenile Toxicology Studies....Pages 231-261
Clinical Assays for Biological Macromolecules....Pages 263-294
Recent Research Projects by the FDA’s Pharmacology and Toxicology Statistics Team....Pages 295-348
Design and Evaluation of Drug Combination Studies....Pages 349-363
Biomarkers....Pages 365-380
Front Matter....Pages 381-381
Overview of Drug Development and Statistical Tools for Manufacturing and Testing....Pages 383-414
Assay Validation....Pages 415-432
Lifecycle Approach to Bioassay....Pages 433-460
Quality by Design: Building Quality into Products and Processes....Pages 461-499
Process Validation in the Twenty-First Century....Pages 501-531
Acceptance Sampling....Pages 533-548
Front Matter....Pages 381-381
Process Capability and Statistical Process Control....Pages 549-573
Statistical Considerations for Stability and the Estimation of Shelf Life....Pages 575-604
In Vitro Dissolution Testing: Statistical Approaches and Issues....Pages 605-630
Assessing Content Uniformity....Pages 631-651
Chemometrics and Predictive Modelling....Pages 653-673
Statistical Methods for Comparability Studies....Pages 675-694
Back Matter....Pages 695-698
