Drug development is an iterative process. The recent publications of
regulatory guidelines further entail a lifecycle approach. Blending data
from disparate sources, the Bayesian approach provides a flexible
framework for drug development. Despite its advantages, the uptake of
Bayesian methodologies is lagging behind in the field of pharmaceutical
development.
Written specifically for pharmaceutical practitioners, Bayesian
Analysis with R for Drug Development: Concepts, Algorithms, and Case
Studies, describes a wide range of Bayesian applications to problems
throughout pre-clinical, clinical, and Chemistry, Manufacturing, and
Control (CMC) development. Authored by two seasoned statisticians in the
pharmaceutical industry, the book provides detailed Bayesian solutions
to a broad array of pharmaceutical problems.
Features
- Provides a single source of information on Bayesian statistics for
drug development
- Covers a wide spectrum of pre-clinical, clinical, and CMC topics
- Demonstrates proper Bayesian applications using real-life examples
- Includes easy-to-follow R code with Bayesian Markov Chain Monte Carlo
performed in both JAGS and Stan Bayesian software platforms
- Offers sufficient background for each problem and detailed description
of solutions suitable for practitioners with limited Bayesian
knowledge
Harry Yang, Ph.D., is Senior Director and Head of Statistical
Sciences at AstraZeneca. He has 24 years of experience across all
aspects of drug research and development and extensive global regulatory
experiences. He has published 6 statistical books, 15 book chapters, and
over 90 peer-reviewed papers on diverse scientific and statistical
subjects, including 15 joint statistical works with Dr. Novick. He is a
frequent invited speaker at national and international conferences. He
also developed statistical courses and conducted training at the FDA and
USP as well as Peking University.
Steven Novick, Ph.D., is Director of Statistical Sciences at
AstraZeneca. He has extensively contributed statistical methods to the
biopharmaceutical literature. Novick is a skilled Bayesian computer
programmer and is frequently invited to speak at conferences, having
developed and taught courses in several areas, including
drug-combination analysis and Bayesian methods in clinical areas. Novick
served on IPAC-RS and has chaired several national statistical
conferences.
