Quantitative Drug Safety and Benefit Risk Evaluation: Practical and Cross-Disciplinary Approaches

— —

William Wang Melvin Munsaka

Quantitative Drug Safety and Benefit Risk Evaluation

Practical and Cross-Disciplinary Approaches

William Wang, Melvin Munsaka, James Buchanan , Judy Li

$284

Hardback

Not in-store but you can order this
How long will it take?

Availability Information

We source books from suppliers in Australia and overseas. For books we don't currently have in stock, the time it takes to get them from our suppliers can vary widely - from a few days to a few months - so we check each book with each supplier to determine the expected time it will take to be supplied to us.

We then advise you accordingly. If the time taken to get any book is too long for you, you can let us know and we will cancel or adjust your order, and refund as required.

To find out the anticipated arrival time for specific items prior to ordering, please contact us by phone or email:

Phone +61 2 9264 3111, or 1800 4 BOOKS (1800 4 26657) if outside Sydney:
option 1 Abbey's Bookshop (Crime, History, Science, Kids & more) • info@abbeys.com.au
option 2 Language Book Centre (ESL & Foreign Languages) • language@abbeys.com.au
option 3 Galaxy Bookshop (Sci-fi, Fantasy, Romance, Graphic Novels) • sf@galaxybooks.com.au

QTY:

English

CRC Press
31 December 2021

Clinical trials; Pharmacology; Pharmaceutical technology

Series: Chapman & Hall/CRC Biostatistics Series

Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual adverse event reports however recently there had been a shift towards aggregate analysis to better understand the scope of product risks.

Written to be accessible not only to statisticians but also to safety scientists with a quantitative interest, this book aims to bridge the gap in knowledge between medical and statistical fields creating a truly multi-disciplinary approach that is very much needed for 21st century safety evaluation.

Edited by: William Wang, Melvin Munsaka, James Buchanan, Judy Li
Imprint: CRC Press
Country of Publication: United Kingdom
Dimensions: Height: 234mm, Width: 156mm,
Weight: 680g
ISBN: 9781138594067
ISBN 10: 1138594067
Series: Chapman & Hall/CRC Biostatistics Series
Pages: 382
Publication Date: 31 December 2021
Audience: Professional and scholarly , Undergraduate
Format: Hardback
Publisher's Status: Active

1 The Emergence of Aggregate Safety Assessment Across the Regulatory Landscape 2 Aggregate Safety Assessment Planning in Clinical Development 3 Safety Signaling and Causal Evaluation 4 Safety Monitoring through External Committees 5 An Overview on Statistical Methodologies for Safety Monitoring and Benefit-Risk Assessment 6 Quantitative Methods for Blinded Safety Monitoring 7 Bayesian Safety Methodology 8 Likelihood-Based Methods for Safety Monitoring 9 Meta-Analysis for Drug Safety Assessment 10 Design consideration for pragmatic trials with insight from cardiovascular outcome trials 11 Post-market Safety Assessment Using Observational Studies and the FDA Sentinel System 12 Analysis Considerations for Real-World Evidence and Clinical Trials Related to Safety 13 Trends and Recent Progress in Benefit-Risk Assessment Planning for Medical Products and Devices 14 Estimands in Safety and Benefit Risk Evaluation 15 Visual Analytics for Safety and Benefit Risk Evaluation

Dr. William (Bill) Wang is currently Executive Director in the department of Biostatistics and Research Decision Sciences, Merck Research Laboratories, where he has worked for 20+ years. Bill has served as the deputy topics-leader for the ICH E17 Working Group and has co-chaired the ASA Biopharmaceutical Safety Working Group. He is an elected ASA Fellow. Dr. Melvin S. Munsaka is currently Senior Director and Head of Safety Statistics at AbbVie. He has more than 25 years of industry experience. He is a member of the ASA Biopharmaceutical Safety Scientific Working Group, DIA Bayesian Scientific Working Group, and the PHUSE Safety Analytics Working Group Dr. James Buchanan, president of Covilance LLC, has 30+ years of drug safety experience in the pharmaceutical industry. He is a co-lead of the ASA Biopharmaceutical Safety Working Group and the Interactive Safety Graphics taskforce that is developing novel, open-source, interactive graphical tools to evaluate drug safety issues. Dr. Judy X. Li is currently Senior Director, Biostatistics Lead for San Diego site Bristol Myers Squibb. She also has extensive experience working at the US Food and Drug Administration as a master statistical reviewer and supervisory mathematical statistician. She is the founding co-chair of the ASA Biopharmaceutical Safety Working Group.

Reviews for Quantitative Drug Safety and Benefit Risk Evaluation: Practical and Cross-Disciplinary Approaches

This is an amazing book for anyone working in the clinical research industry and does not require at all extensive knowledge of statistics or prior exposure to statistics at all. In fact, I would say that the target audience is broader than just statisticians but including instead everyone working in the clinical research industry involved in study planning, analysis and/or reporting. - David Manteigas, ISCB News, September 2022. Overall, this book provides thorough background andknowledge about clinical considerations and regulatory policies, as well as a comprehensive review of frequently used safety-specific statistical methods with clear and thoughtful explanations... Therefore, I strongly recommend this book to all who eithe ralready work on clinical studies or who are new to the area and are interested in clinical trial planning and analyses. - Huan Wang, The American Statistician, January 2023.