| Title:
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BENEFIT-RISK ASSESSMENT OF MEDICINES
THE DEVELOPMENT AND APPLICATION OF A UNIVERSAL FRAMEWORK FOR DECISION-MAKING AND EFFECTIVE COMMUNICATION |
| By: |
James Leong, Prof. Sam Salek, Prof. Stuart Walker |
| Format: |
Hardback |
| List price:
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£44.99 |
| Our price: |
£38.24 |
| Discount: |
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£6.75 |
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| ISBN 10: |
331915804X |
| ISBN 13: |
9783319158044 |
| Availability: |
Usually dispatched within 1-3 weeks.
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| Stock: |
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| Publisher: |
SPRINGER INTERNATIONAL PUBLISHING AG |
| Pub. date: |
22 April, 2015 |
| Edition: |
2015 ed. |
| Pages: |
317 |
| Description: |
Benefit-Risk Assessment of Medicines |
| Synopsis: |
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. |
| Illustrations: |
138 Illustrations, color; 25 Illustrations, black and white; XIII, 317 p. |
| Publication: |
Switzerland |
| Imprint: |
Adis |
| Returns: |
Returnable |