Librería: Open Books, Chicago, IL, Estados Unidos de America
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Idioma: Inglés
Publicado por Chapman and Hall/CRC 2022-05-23, 2022
ISBN 10: 0367561786 ISBN 13: 9780367561789
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Añadir al carritoCondición: New. 1st edition NO-PA16APR2015-KAP.
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Añadir al carritoHardcover. Condición: Brand New. 1st edition. 307 pages. 10.25x7.00x1.00 inches. In Stock.
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Añadir al carritoGebunden. Condición: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Wei Zhang is the Vice President, Head of Biometrics at AffaMed Therapeutics, New York.Fangrong Yan is a Professor of Biostatistics in the School of Science, and Director of Biostatistics and Computational Pharmacy Research Center at .
Idioma: Inglés
Publicado por Chapman And Hall/CRC Mai 2022, 2022
ISBN 10: 0367561786 ISBN 13: 9780367561789
Librería: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, Alemania
EUR 208,00
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Añadir al carritoBuch. Condición: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields.Key Features:Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development.Makes recommendations to evaluate submissions accurately and reliably.Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development.Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases. 318 pp. Englisch.
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Añadir al carritoBuch. Condición: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields.Key Features:Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development.Makes recommendations to evaluate submissions accurately and reliably.Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development.Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.