Bayesian Methods in Pharmaceutical Research

Herausgeber: Lesaffre, Emmanuel; Boulanger, Bruno; Baio, Gianluca

• Gebundenes Buch

Produktbeschreibung

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.

Produktdetails

• Verlag: Chapman and Hall/CRC
• Seitenzahl: 548
• Erscheinungstermin: 27. April 2020
• Englisch
• Abmessung: 260mm x 183mm x 34mm
• Gewicht: 1213g
• ISBN-13: 9781138748484
• ISBN-10: 113874848X
• Artikelnr.: 59479265

Autorenporträt

Emmanuel Lesaffre, Gianluca Baio, Bruno Boulanger

Inhaltsangabe

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