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Benefit-Risk Assessment of Medicines The Development and Application of a Universal Framework for Decision-Making and Effective Communication /
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 benefi...
| Clasificación: | Libro Electrónico |
|---|---|
| Autores principales: | , , |
| Autor Corporativo: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Cham :
Springer International Publishing : Imprint: Adis,
2015.
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| Edición: | 1st ed. 2015. |
| Temas: | |
| Acceso en línea: | Texto Completo |
MARC
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| 001 | 978-3-319-15805-1 | ||
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| 005 | 20220117044529.0 | ||
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| 008 | 150421s2015 sz | s |||| 0|eng d | ||
| 020 | |a 9783319158051 |9 978-3-319-15805-1 | ||
| 024 | 7 | |a 10.1007/978-3-319-15805-1 |2 doi | |
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| 100 | 1 | |a Leong, James. |e author. |4 aut |4 http://id.loc.gov/vocabulary/relators/aut | |
| 245 | 1 | 0 | |a Benefit-Risk Assessment of Medicines |h [electronic resource] : |b The Development and Application of a Universal Framework for Decision-Making and Effective Communication / |c by James Leong, Sam Salek, Stuart Walker. |
| 250 | |a 1st ed. 2015. | ||
| 264 | 1 | |a Cham : |b Springer International Publishing : |b Imprint: Adis, |c 2015. | |
| 300 | |a XIII, 317 p. 163 illus., 138 illus. in color. |b online resource. | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 347 | |a text file |b PDF |2 rda | ||
| 505 | 0 | |a 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. | |
| 520 | |a 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. | ||
| 650 | 0 | |a Pharmacovigilance. | |
| 650 | 0 | |a Quality of life. | |
| 650 | 1 | 4 | |a Drug Safety and Pharmacovigilance. |
| 650 | 2 | 4 | |a Quality of Life Research. |
| 700 | 1 | |a Salek, Sam. |e author. |4 aut |4 http://id.loc.gov/vocabulary/relators/aut | |
| 700 | 1 | |a Walker, Stuart. |e author. |4 aut |4 http://id.loc.gov/vocabulary/relators/aut | |
| 710 | 2 | |a SpringerLink (Online service) | |
| 773 | 0 | |t Springer Nature eBook | |
| 776 | 0 | 8 | |i Printed edition: |z 9783319158068 |
| 776 | 0 | 8 | |i Printed edition: |z 9783319158044 |
| 776 | 0 | 8 | |i Printed edition: |z 9783319367675 |
| 856 | 4 | 0 | |u https://doi.uam.elogim.com/10.1007/978-3-319-15805-1 |z Texto Completo |
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| 950 | |a Medicine (SpringerNature-11650) | ||
| 950 | |a Medicine (R0) (SpringerNature-43714) | ||