Bayesian Methods in Pharmaceutical Research

by Randy Moore in , , , on September 3, 2020
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Book Description

Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the research, development, manufacturing, and health economic evaluation of new health care interventions. In 2010, the first Applied Bayesian Biostatistics conference was held, with the primary objective to stimulate the practical implementation of Bayesian statistics, and to promote the added-value for accelerating the discovery and the delivery of new cures to patients.

This book is a synthesis of the conferences and debates, providing an overview of Bayesian methods applied to nearly all stages of research and development, from early discovery to portfolio management. It highlights the value associated with sharing a vision with the regulatory authorities, academia, and pharmaceutical industry, with a view to setting up a common strategy for the appropriate use of Bayesian statistics for the benefit of patients.

The book covers:

  • Theory, methods, applications, and computing
  • Bayesian biostatistics for clinical innovative designs
  • Adding value with Real World Evidence
  • Opportunities for rare, orphan diseases, and pediatric development
  • Applied Bayesian biostatistics in manufacturing
  • Decision making and Portfolio management
  • Regulatory perspective and public health policies

Statisticians and data scientists involved in the research, development, and approval of new cures will be inspired by the possible applications of Bayesian methods covered in the book. The methods, applications, and computational guidance will enable the reader to apply Bayesian methods in their own pharmaceutical research.


I Introduction 
1 Bayesian Background
2 FDA Regulatory Acceptance of Bayesian Statistics
3 Bayesian Tail Probabilities for Decision Making
II Clinical development
4 Clinical Development in the Light of Bayesian Statistics
5 Prior Elicitation
6 Use of Historical Data
7 Dose Ranging Studies and Dose Determination
8 Bayesian Adaptive Designs in Drug Development
9 Bayesian Methods for Longitudinal Data with Missingness
10 Survival Analysis and Censored Data
11 Benefit of Bayesian Clustering of Longitudinal Data: Study of Cognitive Decline for Precision Medicine
12 Bayesian Frameworks for Rare Disease Clinical Development Programs
13 Bayesian Hierarchical Models for Data Extrapolation and Analysis in Pediatric Disease Clinical Trials
III Post-marketing
14 Bayesian Methods for Meta-Analysis
15 Economic Evaluation and Cost-Effectiveness of Health Care Interven-tions
16 Bayesian Modeling for Economic Evaluation Using “Real-World Evi-dence”
17 Bayesian Benefit-Risk Evaluation in Pharmaceutical Research
IV Product development and manufacturing 
18 Product Development and Manufacturing
19 Process Development and Validation
20 Analytical Method and Assay
21 Bayesian Methods for the Design and Analysis of Stability Studies
22 Content Uniformity Testing
23 Bayesian Methods for In Vitro Dissolution Drug Testing and Similarity Comparisons
24 Bayesian Statistics for Manufacturing
V Additional topics 
25 Bayesian Statistical Methodology in the Medical Device Industry
26 Program and Portfolio Decision-Making

Book Details

  • Title: Bayesian Methods in Pharmaceutical Research
  • Length: 547 pages
  • Edition: 1
  • Publisher: Chapman and Hall/CRC
  • Publication Date: 2020-04-27
  • ISBN-10: 113874848X
  • ISBN-13: 9781138748484
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  • Released

    September 3, 2020

  • Last Updated

    September 3, 2020

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