Nonclinical Statistics for Pharmaceutical and Biotechnology Industries (Statistics for Biology and Health)

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.--Résumé de l'éditeur 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 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.--Résumé de l'éditeur