Harry (Hrsg.) Yang

Real-World Evidence in Drug Development and Evaluation

Ebook (PDF Format)

Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field.Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With co… Mehr

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Produktdetails

Weitere Autoren: Yu, Binbing (Hrsg.)

ISBN: 978-0-429-67682-6
EAN: 9780429676826
Produktnummer: 35392792
Verlag: Taylor & Francis Ltd.
Sprache: Englisch
Erscheinungsjahr: 2021
Seitenangabe: 208 S.
Plattform: PDF
Masse: 7'279 KB
Auflage: 1. Auflage
Abbildungen: 30 schwarz-weiße Abbildungen, 20 schwarz-weiße Tabellen

Über den Autor

Harry Yang, Ph.D., is Vice President and Head of Biometrics at Fate Therapeutics. He has 25 years of experience across all aspects of drug research and development, from early target discovery, through pre-clinical, clinical, and CMC programs to regulatory approval and post-approval lifecycle management. He has published 7 statistical books, 15 book chapters, and over 90 peer-reviewed papers on diverse scientific and statistical subjects. He is a frequent invited speaker at national and international conferences. He also developed statistical courses and conducted training at the FDA and USP.Binbing Yu, Ph.D., is Associate Director in the Oncology Statistical Innovation group at AstraZeneca. He serves as the statistical expert across the whole spectrum of drug R&D, including drug discovery, clinical trials, operation and manufacturing, clinical pharmacology, oncology medical affairs and post-marketing surveillance. He obtained his PhD in Statistics from the George Washington University. His primary research interests are clinical trial design and analysis, cancer epidemiology, causal inference in observation studies, PKPD modeling and Bayesian analysis.