Benefit-risk assessment in pharmaceutical research and development

Autore: Sashegyi A. Felli J. Casa Editrice: Chapman & Hall / Crc  Anno Edizione: 2013 Edizione: 1 ISBN: 9781439867945 Pagine: 224 Costo: 96,65 Euro (*) Materia: Chimica farmaceutica e cosmesi Gestione del Rischio Aziendale Statistica e Demografia Testi stranieri Lingua: Inglese

This work presents an overview of benefit-risk assessment approaches for pharmaceutical research and development. It covers various decision-making points along the R&D spectrum that would benefit from benefit risk analysis, including during lead development and optimization, early and late planning of clinical development, and regulatory review. The book also looks at health outcomes and comparative effectiveness analysis. In addition, the authors address current and future barriers to using risk-benefit modeling, including greater regulatory acceptance.