Benefit-Risk Assessment Methods in Medical Product Development (ePub)
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This book provides guidance on selecting specific benefit-risk (B-R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B-R assessment in clinical development and regulatory submission. The book delineates approaches for uncertainty quantifications, describes how to elicit patients' views on benefits and risks, and explains how to select the appropriate B-R method for various evaluation settings. It also covers the graphical presentation of a B-R profile.
Dr. Weili He is a director of clinical biostatistics at Merck & Co., Inc. Her research interests include survival and longitudinal data modeling, missing data imputation, cancer Phase I and II designs, repeated categorical data modeling, surrogate marker evaluations, adaptive design methodologies and implementations, and methods for benefit-risk assessment. Dr. He has published extensively in the areas of adaptive designs and benefit-risk evaluations and is the author of more than 50 peer-reviewed publications in statistical and medical journals. She is also a lead editor of the book Practical Considerations for Adaptive Trial Design and Implementation. She has been actively involved in many professional activities and services, including serving as co-chair of the Quantitative Sciences in the Pharmaceutical Industry (QSPI) Benefit-Risk Working Group, co-chair of the DIA Adaptive Design Scientific
- 2017, 312 Seiten, Englisch
- Herausgegeben: Qi Jiang, Weili He
- Verlag: Taylor & Francis
- ISBN-10: 1315355019
- ISBN-13: 9781315355016
- Erscheinungsdatum: 19.12.2017
Abhängig von Bildschirmgröße und eingestellter Schriftgröße kann die Seitenzahl auf Ihrem Lesegerät variieren.
- Dateiformat: ePub
- Größe: 6.06 MB
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