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[null,"1.","Record Nr.",null,"UNINA9910300234003321"]
[null,null,"Autore",null,"Leong James"]
[null,null,"Titolo",null,"Benefit-Risk Assessment of Medicines : The Development and Application of a Universal Framework for Decision-Making and Effective Communication / / by James Leong, Sam Salek, Stuart Walker"]
[null,null,"Pubbl/distr/stampa",null,"Cham : , : Springer International Publishing : , : Imprint : Adis, , 2015"]
[null,null,"ISBN",null,"3-319-15805-8"]
[null,null,"Edizione",null,"[1st ed. 2015.]"]
[null,null,"Descrizione fisica",null,"1 online resource (326 p.)"]
[null,null,"Disciplina",null,"306"]
[{"$nulls":4},"353998"]
[{"$nulls":4},"610"]
[null,null,"Soggetti",null,"Pharmacy"]
[{"$nulls":4},"Medicine - Research"]
[{"$nulls":4},"Drug Safety and Pharmacovigilance"]
[{"$nulls":4},"Quality of Life Research"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Note generali","Description based upon print version of record."]
[null,null,null,"Nota di bibliografia","Includes bibliographical references."]
[null,null,"Nota di contenuto",null,"Prologue -- Preface -- Overview -- Approaches to utilising decision-making framework -- Benefit-risk assessment of medicines by pharmaceutical companies and regulatory authorities -- Development of a universal benefit-risk framework and template -- Implementation of the benefit-risk assessment template by mature agencies -- Implementation of the benefit- risk summary template by a maturing agency: A case study -- Communicating benefit-risk decisions by US FDA, EMA, TGA and Health Canada -- Conclusions and future directions -- References."]
[null,null,null,"Sommario/riassunto","This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as "]
[{"$nulls":4},"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."]