Quantitative Drug Safety and Benefit Risk Evaluation: Practical and Cross-Disciplinary Approaches (Chapman & Hall/CRC Biostatistics Series) - Tapa dura

Libro 131 de 155: Chapman & Hall/CRC Biostatistics
 
9781138594067: Quantitative Drug Safety and Benefit Risk Evaluation: Practical and Cross-Disciplinary Approaches (Chapman & Hall/CRC Biostatistics Series)
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ISBN 10: 1138594067 ISBN 13: 9781138594067
Editorial: Chapman and Hall/CRC, 2021

Sinopsis

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.

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Acerca del autor

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.

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Editorial
Chapman and Hall/CRC
Año de publicación
2021
Idioma
Inglés
ISBN 10 
1138594067
ISBN 13 
9781138594067
Encuadernación
Tapa dura
Número de edición
1
Número de páginas
382
Editor
Wang William, Munsaka Melvin, Buchanan James, Li Judy
Contacto del fabricante
Taylor and Francis, GPSR Taylor and Francis
gpsr@taylorandfrancis.com

Taylor & Francis Verlag GmbH, Kaufingerstraße 24
München
80331
Alemania

Otras ediciones populares con el mismo título

9781032191119: Quantitative Drug Safety and Benefit Risk Evaluation: Practical and Cross-Disciplinary Approaches (Chapman & Hall/CRC Biostatistics Series)

Edición Destacada

ISBN 10:  1032191112 ISBN 13:  9781032191119
Editorial: Chapman and Hall/CRC, 2024
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