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Case Studies in Bayesian Methods for Biopharmaceutical CMC book cover

1st Edition

Case Studies in Bayesian Methods for Biopharmaceutical CMC

Edited By Paul Faya, Tony Pourmohamad Copyright 2023
354 Pages 134 B/W Illustrations
by Chapman & Hall

354 Pages 134 B/W Illustrations
by Chapman & Hall
Also available as eBook on:
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,... Read more

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.

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