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Title Quantitative evaluation of safety in drug development : design, analysis and reporting / edited by Qi Jiang, H. Amy Xi
Published Boca Raton : Chapman & Hall/CRC, 2014


Description 1 online resource
Series Chapman & Hall/CRC Biostatistics Series
Chapman & Hall/CRC biostatistics series
Contents Front Cover; Contents; Preface; Editors; Contributors; Chapter 1: Incorporating Quantitative Safety Evaluation into Risk Management; Chapter 2: Bayesian Meta-Experimental Design for Evaluating Cardiovascular Risk; Chapter 3: Non-Inferiority Study Design and Analysis for Safety Endpoints; Chapter 4: Program Safety Analysis Plan: An Implementation Guide; Chapter 5: Why a DMC Safety Report Differs from a Safety Section Written at the End of the Trial; Chapter 6: Safety Surveillance and Signal Detection Process; Chapter 7: Bayesian Adaptive Trials for Drug Safety
Chapter 8: Observational Safety Study Design, Analysis, and ReportingChapter 9: Emerging Role of Observational Health-Care Data in Pharmacovigilance; Chapter 10: Roadmap for Causal Inference in Safety Analysis; Chapter 11: Safety Graphics; Chapter 12: Bayesian Network Meta-Analysis for Safety Evaluation; Chapter 13: Regulatory Issues in Meta-Analysis of Safety Data; Chapter 14: Bayesian Applications for Drug Safety Evaluation; Chapter 15: Risk-Benefit Assessment Approaches; Chapter 16: Detecting Safety Signals in Subgroups
Summary State-of-the-Art Methods for Drug Safety AssessmentResponding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment. The book's three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry,
Bibliography Includes bibliographical references and index
Notes CIP data; item not viewed
Subject Drugs -- Testing.
Drug development.
Drug development.
Drugs -- Testing.
Form Electronic book
Author Jiang, Qi (Biostatistician), editor
Xi, H. Amy, editor
ISBN 9781466555471