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Therapeutic risk management of medicines /
Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities,...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Cambridge :
Woodhead Publishing,
�2014.
|
| Colección: | Woodhead Publishing series in biomedicine ;
no. 30. |
| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 100 | 1 | |a Mayall, Stephen J. | |
| 245 | 1 | 0 | |a Therapeutic risk management of medicines / |c Stephen J. Mayall and Anjan K. Banerjee. |
| 260 | |a Cambridge : |b Woodhead Publishing, |c �2014. | ||
| 300 | |a 1 online resource | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 490 | 1 | |a Woodhead publishing series in biomedicine ; |v no. 30 | |
| 588 | 0 | |a Print version record. | |
| 505 | 0 | |a Front Cover; Therapeutic risk management of medicines; Copyright; Contents; List of figures and tables; Figures; Tables; List of abbreviations; Acknowledgements; Foreword; About the authors; Additional contributors; Part 1 Background to therapeutic risk management; 1 Introduction; 1.1 The importance of therapeutic risk management; 1.2 Relevant audiences for and structure of this book; 2Basic principles of therapeutic risk management; 2.1 What is therapeutic risk management?; 2.2 The benefit-risk balance of a medicine; 2.3 Participants in therapeutic risk management. | |
| 505 | 8 | |a 2.4 Risk management during the product lifecycleNotes; References; 3The evolution of therapeutic risk management; 3.1 The importance of a historical perspective; 3.2 The early foundations for therapeutic risk management; 3.3 Major drug safety incidents that influenced risk management; 3.4 Risk minimisation emerges for effective but risky medicines; 3.5 The modern era of risk management; References; 4Risk management in the European Union; 4.1 Overview of the risk management approach in the EU; 4.2 The EU-RMP; 4.3 The periodic safety update report (PSUR); Notes; References. | |
| 505 | 8 | |a 5Risk management in the United States5.1 Overview of the US risk management approach; 5.2 Risk evaluation and mitigation strategies (REMS); 5.3 Experience of REMS in practice; 5.4 Other US risk management guidance and requirements; Notes; References; 6Overview of risk management around the world; 6.1 Risk management varies around the world; 6.2 Comparing EU and US approaches to risk management; 6.3 Risk management in other advanced markets; 6.4 Risk management in emerging markets; Note; References; Part 2 Developing a risk management plan. | |
| 505 | 8 | |a 7Developing a safety specification and selecting risks7.1 Structure of a safety specification; 7.2 Contents of an EU-RMP safety specification; 7.3 Selecting important risks and missing information; 7.4 Practical advice for writing a safety specification; References; 8Pharmacovigilance planning; 8.1 Overview of pharmacovigilance planning; 8.2 The EU-RMP pharmacovigilance plan; 8.3 Pharmacovigilance planning in the US; 8.4 Routine pharmacovigilance activities; 8.5 The need for and selection of additional pharmacovigilance activities; 8.6 Types of additional pharmacovigilance activities; Notes. | |
| 520 | |a Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders. A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved ra. | ||
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| 650 | 7 | |a Drugs |x Side effects |2 fast |0 (OCoLC)fst00898912 | |
| 700 | 1 | |a Banerjee, Anjan K. | |
| 776 | 0 | 8 | |i Print version: |z 9781306674447 |
| 830 | 0 | |a Woodhead Publishing series in biomedicine ; |v no. 30. | |
| 856 | 4 | 0 | |u https://sciencedirect.uam.elogim.com/science/book/9781907568480 |z Texto completo |