Introduction to Nonclinical Statistics for Pharmaceutical and Biotechnology Industries -- Regulatory Nonclinical Statistics -- How to be a good nonclinical statistician -- Statistical Methods for Drug Discovery -- High-throughput Screening Data Analysis -- Quantitative-Structure Activity Relationship Modeling and  Cheminformatics -- GWAS for Drug Discovery -- Statistical applications in Design and Analysis of In-Vitro Safety Screening Assays -- Nonclinical safety assessment: an introduction for statisticians -- General Toxicology, Safety Pharmacology, Reproductive Toxicology and Juvenile Toxicology Studies -- Clinical Assays for Biological Macromolecules -- Recent Research Projects by FDA's Pharmacology and Toxicology Statistics Team -- Design and evaluation of drug combination studies -- Biomarkers -- Overview of Drug Development and Statistical Tools for Manufacturing and Testing -- Assay Validation -- Lifecycle Approach to Bioassay -- Quality by Design: Building Quality into Products and Processes -- Process Validation -- Acceptance Sampling -- Process Capability and Statistical Process Control -- Statistical Considerations for Stability and the Estimation of Shelf Life.- In Vitro Dissolution Testing: Statistical Approaches and Issues -- Assessing Content Uniformity -- Chemometrics and Predictive Modelling -- Statistical Methods for Comparability Studies.