1st Edition
Bayesian Methods in Pharmaceutical Research
I Introductory Part
Chapter 1: Bayesian Background
Emmanuel Lesaffre and Gianluca Baio
Chapter 2: FDA Regulatory Acceptance of Bayesian Statistics
Gregory Campbell
Chapter 3: Bayesian Tail Probabilities for Decision Making
Leonhard Held
II Clinical Development
Chapter 4: Clinical Development in the Light of Bayesian Statistics
David Ohlssen
Chapter 5: Prior Elicitation
Nicky Best, Nigel Dallow, and Timothy Montague
Chapter 6: Use of Historical Data
Beat Neuenschwander and Heinz Schmidli
Chapter 7: Dose Ranging Studies and Dose Determination
Phil Woodward, Alun Bedding, and David Dejardin
Chapter 8: Bayesian Adaptive Designs in Drug Development
Gary L. Rosner
Chapter 9: Bayesian Methods for Longitudinal Data with Missingness
Michael J. Daniels and Dandan Xu
Chapter 10: Survival Analysis and Censored Data
Linda D. Sharples and Nikolaos Demiris
Chapter 11: Benefit of Bayesian Clustering of Longitudinal Data: Study of Cognitive Decline for Precision Medicine
Anais Rouanet, Sylvia Richardson, and Brian Tom
Chapter 12: Bayesian Frameworks for Rare Disease Clinical Development Programs
Freda Cooner, Forrest Williamson, and Bradley P. Carlin
Chapter 13: Bayesian Hierarchical Models for Data Extrapolation and Analysis in Pediatric Disease Clinical Trials
Cynthia Basu and Bradley P. Carlin
III Post-Marketing
Chapter 14: Bayesian Methods for Meta-Analysis
Nicky J Welton, Haley E Jones, and Sofia Dias
Chapter 15: Economic Evaluation and Cost-Effectiveness of Health Care Interventions
Nicky J Welton, Mark Strong, Christopher Jackson, and Gianluca Baio
Chapter 16: Bayesian Modeling for Economic Evaluation Using "Real World Evidence"
Gianluca Baio
Chapter 17: Bayesian Benefit-Risk Evaluation in Pharmaceutical Research
Carl Di Casoli, Yueqin Zhao, Yannis Jemiai, Pritibha Singh, and Maria Costa
IV Product Development and Manufacturing
Chapter 18: Product Development and Manufacturing
Bruno Boulanger and Timothy Mutsvari
Chapter 19: Process Development and Validation
John J. Peterson
Chapter 20: Analytical Method and Assay
Pierre Lebrun and Eric Rozet
Chapter 21: Bayesian Methods for the Design and Analysis of Stability Studies
Tonakpon Hermane Avohou, Pierre Lebrun, Eric Rozet, and Bruno Boulanger
Chapter 22: Content Uniformity Testing
Steven Novick and Buffy Hudson-Curtis
Chapter 23: Bayesian methods for in vitro dissolution drug testing and similarity comparisons
Linas Mockus and Dave LeBlond
Chapter 24: Bayesian Statistics for Manufacturing
Tara Scherder and Katherine Giacoletti
V Additional Topics
Chapter 25: Bayesian Statistical Methodology in the Medical Device Industry
Tarek Haddad
Chapter 26: Program and Portfolio Decision-Making
Nitin Patel, Charles Liu, Masanori Ito, Yannis Jemiai, Suresh Ankolekar, and Yusuke Yamaguchi
Biography
Emmanuel Lesaffre, Gianluca Baio, Bruno Boulanger
