BENEFIT-RISK ASSESSMENT OF MEDICINES

The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is also reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Therefore, this is not an attempt to provide a comprehensive and complete account of the current benefit-risk assessment environment; rather, the strength of this book is that it provides an evaluation of some current approaches to the benefit-risk assessment of medicines and outlines the development of a new universal framework. It also demonstrates how a number of mature agencies have implemented this universal framework together with the methodology for documenting their benefit-risk decisions. In addition, it also reviews current publicly available documents together with their strengths and weaknesses in communicating benefit-risk decisions to stakeholders.

Idioma: INGLÉS