I Introductory part

Chapter 1: Bayesian Background

Chapter 2: FDA Regulatory Acceptance of Bayesian Statistics

Chapter 3: Bayesian Tail Probabilities for Decision Making

II Clinical development

Chapter 4: Clinical Development in the Light of Bayesian Statistics

Chapter 5: Prior Elicitation

Chapter 6: Use of Historical Data

Chapter 7: Dose Ranging Studies and Dose Determination

Chapter 8: Bayesian Adaptive Designs in Drug Development

Chapter 9: Bayesian Methods for Longitudinal Data with Missingness

Chapter 10: Survival Analysis and Censored Data

Chapter 11: Benefit of Bayesian Clustering of Longitudinal Data: Study of Cognitive Decline for Precision Medicine

Chapter 12: Bayesian Frameworks for Rare Disease Clinical Development Programs

Chapter 13: Bayesian Hierarchical Models for Data Extrapolation and Analysis in Pediatric Disease Clinical Trials

III Post-marketing

Chapter 14: Bayesian Methods for Meta-Analysis

Chapter 15: Economic Evaluation and Cost-Effectiveness of Health Care Interventions

Chapter 16: Bayesian Modeling for Economic Evaluation Using "Real World Evidence"

Chapter 17: Bayesian Benefit-Risk Evaluation in Pharmaceutical Research

IV Product development and manufacturing

Chapter 18: Product Development and Manufacturing

Chapter 19: Process Development and Validation

Chapter 20: Analytical Method and Assay

Chapter 21: Bayesian Methods for the Design and Analysis of Stability Studies

Chapter 22: Content Uniformity Testing

Chapter 23: Bayesian methods for in vitro dissolution drug testing and similarity comparisons

Chapter 24: Bayesian Statistics for Manufacturing

V Additional topics

Chapter 25: Bayesian Statistical Methodology in the Medical Device Industry

Chapter 26: Program and Portfolio Decision-Making