{"product_id":"9783319158044","title":"Benefit-Risk Assessment of Medicines: The Development and Application of a Universal Framework for Decision-Making and Effective Communication","description":"\u003ch1\u003eBenefit-Risk Assessment of Medicines: The Development and Application of a Universal Framework for Decision-Making and Effective Communication\u003c\/h1\u003e \u003ch2\u003eLeong, James; Salek, Sam; Walker, Stuart\u003c\/h2\u003e \u003cp\u003e\u003c\/p\u003e\u003cp\u003eThis 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.\u003c\/p\u003e\u003cp\u003eOver 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.\u003c\/p\u003eThe 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. \u003ch3\u003eDetails\u003c\/h3\u003e \u003cp\u003ePublished by: Adis\u003c\/p\u003e \u003cp\u003ePublication Date: 2015-05-05\u003c\/p\u003e \u003cp\u003eFormat: Hardcover\u003c\/p\u003e \u003cp\u003eISBN-13: 9783319158044\u003c\/p\u003e \u003cp\u003eDOI: 10.1007\/978-3-319-15805-1\u003c\/p\u003e \u003cp\u003eDimensions: 235cm x155cm\u003c\/p\u003e \u003cp\u003ePages: 317\u003c\/p\u003e ","brand":"Springer International Publishing","offers":[{"title":"Default Title","offer_id":47411417350284,"sku":"9783319158044","price":49.49,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0710\/9545\/1788\/files\/9783319158044.jpg?v=1775842590","url":"https:\/\/fh90cf-fv.myshopify.com\/products\/9783319158044","provider":"Late Knight Books and Services, LLC","version":"1.0","type":"link"}