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
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| Autore: |
Leong James
|
| Titolo: |
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
|
| Pubblicazione: | Cham : , : Springer International Publishing : , : Imprint : Adis, , 2015 |
| Edizione: | 1st ed. 2015. |
| Descrizione fisica: | 1 online resource (326 p.) |
| Disciplina: | 306 |
| 353998 | |
| 610 | |
| Soggetto topico: | Pharmacovigilance |
| Quality of life | |
| Drug Safety and Pharmacovigilance | |
| Quality of Life Research | |
| Persona (resp. second.): | SalekSam |
| WalkerStuart | |
| Note generali: | Description based upon print version of record. |
| Nota di bibliografia: | Includes bibliographical references. |
| Nota di contenuto: | 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. |
| 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 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. |
| Titolo autorizzato: | Benefit-Risk Assessment of Medicines |
| ISBN: | 3-319-15805-8 |
| Formato: | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione: | Inglese |
| Record Nr.: | 9910300234003321 |
| Lo trovi qui: | Univ. Federico II |
| Opac: | Controlla la disponibilità qui |