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

Rilegato

ISBN 10: 1138594067 ISBN 13: 9781138594067

Casa editrice: Chapman and Hall/CRC, 2021

Riassunto

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.

Su questo libro

Informazioni sull?autore

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.

Dettagli dell'edizione

• Editore: Chapman and Hall/CRC
• Data di pubblicazione: 2021
• Lingua: Inglese
• ISBN 10: 1138594067
• ISBN 13: 9781138594067
• Rilegatura: Copertina rigida
• Numero edizione: 1
• Numero di pagine: 382
• Redattore: Wang William, Munsaka Melvin, Buchanan James, Li Judy
• Contatto del produttore: Taylor and Francis, GPSR Taylor and Francis; gpsr@taylorandfrancis.com; ; Taylor & Francis Verlag GmbH, Kaufingerstraße 24; München; 80331; Germania