1st Edition
Case Studies in Bayesian Methods for Biopharmaceutical CMC
The subject of this book is applied Bayesian methods for chemistry, manufacturing, and control (CMC) studies in the biopharmaceutical industry. The book has multiple authors from industry and academia, each contributing a case study (chapter). The collection of case studies covers a broad array of CMC topics, including stability analysis, analytical method development, specification setting, process development and optimization, process control, experimental design, dissolution testing, and comparability studies. The analysis of each case study includes a presentation of code and reproducible output. This book is written with an academic level aimed at practicing nonclinical biostatisticians, most of whom have graduate degrees in statistics.
• First book of its kind focusing strictly on CMC Bayesian case studies
• Case studies with code and output
• Representation from several companies across the industry as well as academia
• Authors are leading and well-known Bayesian statisticians in the CMC field
• Accompanying website with code for reproducibility
• Reflective of real-life industry applications/problems
1. Introduction
Paul Faya and Tony Pourmohamad
2. An Overview of Bayesian Computation
David J. Kahle, John W. Seaman Jr., and James D. Stamey
3. Basic Bayesian Model Checking
John W. Seaman Jr., David J. Kahle, and James D. Stamey
4. Quantitative Decision - Making, a CMC application to analytical method equivalence
Misbah Ahmed and Mike Denham
5. Bayesian Dissolution Testing
Tony Pourmohamad and Robert Richardson
6. A Non-Normal Bayesian Model for the Estimation and Comparison of Immunogenicity Screening Assay Cut-Points
David LeBlond and Robert Singer, Lu Xu, and Rong Zeng
7. Application of Bayesian Hierarchical Models to Experimental Design
Adam P. Rauk and Paul Faya
8. Bayesian Prediction for Staged Testing Procedures
Katherine E.D. Giacoletti and Tara Scherder
9. A Bayesian Approach to Multivariate Conditional Regression Surrogate Modeling with Application to Real Time Release Testing
Stan Altan, Dwaine Banton, Hans Coppenolle, Martin Kovarik and Martin Otava, and Christian Schmid
10. Bayesian Approach for Demonstrating Analytical Similarity
Harry Yang and Steven Novick
11. Bayesian Evaluation and Monitoring of Process Comparability
Ke Wang and Aili Cheng
12. Bayesian Alternatives to Traditional Methods for Estimating Product Shelf Life and Internal Release Limits
Perceval Sondag, Ji Young Kim, Laurent Natalis, and Tara Scherder
13. Application of Bayesian Methods for Specification Setting
Chris Thompson and Guillermo Miro-Quesada
14. Calculating Statistical Tolerance Intervals Using SAS
Richard Lewis and Buffy Hudson-Curtis
15. A Bayesian Application in Process Monitoring – Establishing Limits for Dosage Units in Early Phase Process Control
Yanbing Zheng, James Reynolds, Man Tang, Mark Johnson and Hesham Fahmy
Biography
Paul Faya (Ph.D.) is a Director in Discovery and Development Statistics with Eli Lilly and Company, USA.
Tony Pourmohamad (Ph.D.) is a Principal Statistical Scientist with Genentech, USA, and an Assistant Adjunct Professor in the Department of Statistics at the University of California, Santa Cruz.
