Benefit-Risk Assessment Methods in Medical Product Development

CRC Press

Benefit-Risk Assessment Methods in Medical Product DevelopmentBridging Qualitative and Quantitative Assessments\nAuthor(s): Qi Jiang, Weili He\nFormat: Hardback\nPublisher: Taylor & Francis Inc, United States\nImprint: Chapman & Hall/CRC\nISBN-13: 9781482259360, 978-1482259360\nSynopsis\nGuides You on the Development and Implementation of BR Evaluations\n\nBenefitRisk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefitrisk (BR) 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 BR assessment in clinical development and regulatory submission.\n\nThe first section of the book discusses the role of BR assessments in medicine development and regulation, the need for both a common BR fr.