Bayesian Methods in Pharmaceutical Research -

Bayesian Methods in Pharmaceutical Research

Buch | Hardcover
546 Seiten
2020
CRC Press (Verlag)
978-1-138-74848-4 (ISBN)
168,35 inkl. MwSt
Bayesian methods have emerged as the driving force for methodological development in drug development. This edited book provides broad coverage of Bayesian methods in pharmaceutical research. The book includes contributions from some of the leading researchers in the field, and has been edited to ensure consistency in level and style.
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.

Emmanuel Lesaffre, Gianluca Baio, Bruno Boulanger

I Introductory part

Chapter 1: Bayesian Background

Chapter 2: FDA Regulatory Acceptance of Bayesian Statistics

Chapter 3: Bayesian Tail Probabilities for Decision Making

II Clinical development

Chapter 4: Clinical Development in the Light of Bayesian Statistics

Chapter 5: Prior Elicitation

Chapter 6: Use of Historical Data

Chapter 7: Dose Ranging Studies and Dose Determination

Chapter 8: Bayesian Adaptive Designs in Drug Development

Chapter 9: Bayesian Methods for Longitudinal Data with Missingness

Chapter 10: Survival Analysis and Censored Data

Chapter 11: Benefit of Bayesian Clustering of Longitudinal Data: Study of Cognitive Decline for Precision Medicine

Chapter 12: Bayesian Frameworks for Rare Disease Clinical Development Programs

Chapter 13: Bayesian Hierarchical Models for Data Extrapolation and Analysis in Pediatric Disease Clinical Trials

III Post-marketing

Chapter 14: Bayesian Methods for Meta-Analysis

Chapter 15: Economic Evaluation and Cost-Effectiveness of Health Care Interventions

Chapter 16: Bayesian Modeling for Economic Evaluation Using "Real World Evidence"

Chapter 17: Bayesian Benefit-Risk Evaluation in Pharmaceutical Research

IV Product development and manufacturing

Chapter 18: Product Development and Manufacturing

Chapter 19: Process Development and Validation

Chapter 20: Analytical Method and Assay

Chapter 21: Bayesian Methods for the Design and Analysis of Stability Studies

Chapter 22: Content Uniformity Testing

Chapter 23: Bayesian methods for in vitro dissolution drug testing and similarity comparisons

Chapter 24: Bayesian Statistics for Manufacturing

V Additional topics

Chapter 25: Bayesian Statistical Methodology in the Medical Device Industry

Chapter 26: Program and Portfolio Decision-Making

Erscheinungsdatum
Reihe/Serie Chapman & Hall/CRC Biostatistics Series
Zusatzinfo 59 Tables, black and white; 111 Illustrations, black and white
Verlagsort London
Sprache englisch
Maße 178 x 254 mm
Gewicht 1115 g
Themenwelt Mathematik / Informatik Mathematik
Studium Querschnittsbereiche Epidemiologie / Med. Biometrie
Naturwissenschaften Biologie
Technik
ISBN-10 1-138-74848-X / 113874848X
ISBN-13 978-1-138-74848-4 / 9781138748484
Zustand Neuware
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