Benefit-Risk Assessment of Medicines

The Development and Application of a Universal Framework for Decision-Making and Effective Communication

von James Leong, Sam Salek, Stuart Walker

317 Seiten, Hardcover

Kurzbeschreibung des Verlags

This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox.

Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area.

The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.

• Themen: Medizin Medizinische Spezialgebiete Pharmakologie
• ISBN: 9783319158044
• Sprache: Englisch
• Erscheinungsdatum: 05.05.2015
• Größe: 23.5 x 15.5 cm
• Verlag: Springer International Publishing