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Social aspects of drug discovery, development and commercialization /
This book provides a thorough discussion and analysis of the social factors that affect and influence the drug discovery and development processes, including analysis of important new advances, key scientific and strategic issues, and overviews of recent progress in drug development.
| Clasificación: | Libro Electrónico |
|---|---|
| Autores principales: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
London, UK :
Academic Press is an imprint of Elsevier,
2016.
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| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 100 | 1 | |a Osakwe, Odilia, |e author. | |
| 245 | 1 | 0 | |a Social aspects of drug discovery, development and commercialization / |c Odilia Osakwe, Syed A.A. Rizvi. |
| 264 | 1 | |a London, UK : |b Academic Press is an imprint of Elsevier, |c 2016. | |
| 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 | ||
| 500 | |a Includes index. | ||
| 588 | 0 | |a Online resource; title from PDF title page (ScienceDirect, viewed March 2, 2016). | |
| 505 | 0 | |a Cover; Title Page; Copyright Page; Dedication; Contents; Preface; Introduction; 1 -- Trends in drug discovery; 2 -- The pharmaceutical ecosystem; 3 -- Aspects of the pharmaceutical systems and the stakeholders; 3.1 -- Government and Policies; 3.2 -- Drug Discovery Research and Development; 3.3 -- Economics Models; 3.4 -- The Civic Society; 3.5 -- The Processes; 4 -- The mutual effect of the pharmaceutical systems and society; 4.1 -- Pharmaceutical Policy and Regulation; 4.1.1 -- Patent Linkage; 4.1.2 -- Political Interests; 4.2 -- Access to Drugs; 4.3 -- Drug Pricing and Payment; 4.4 -- Communication. | |
| 505 | 8 | |a 4.4.1 -- Direct-to-Consumer Advertising/Gift Giving4.5 -- Drug Repositioning or Repurposing; 4.6 -- Stratified/Personalized Medicine; 5 -- Cyclical interactions in the pharmaceutical ecosystem; 6 -- The pharmaceutical product lifecycle; 7 -- Conclusions; References; Section I -- Pharmaceutical Industry, Society, and Governance; Chapter 1 -- Pharmaceutical Regulation: The Role of Government in the Business of Drug Discovery; 1.1 -- Introduction; 1.1.1 -- Evolution of the Pharmaceutical Regulatory System; 1.2 -- The legal instruments; 1.2.1 -- The Act/Enabling Act; 1.2.2 -- Regulations; 1.2.3 -- Guidelines. | |
| 505 | 8 | |a 1.3 -- The National Regulatory Authorities and Administration1.3.1 -- The Food and Drug Administration; 1.3.1.1 -- Federal Food, Drug, and Cosmetic Act; 1.3.2 -- Health Canada; 1.3.2.1 -- Canadian Food and Drugs Act; 1.3.3 -- European Medicines Agency; 1.3.3.1 -- The European Drug Regulatory Legislation; 1.3.4 -- Pharmaceuticals and Medical Devices Agency of Japan; 1.3.4.1 -- The Pharmaceutical Affairs Act of Japan; 1.4 -- Analytical framework for regulatory approval: benefit-risk assessment; 1.5 -- The pharmaceutical product life cycle. | |
| 505 | 8 | |a 1.5.1 -- Modules for Drug Regulatory Assessment: The Decision Points1.5.1.1 -- Decision Point I; 1.5.1.2 -- Decision Point II; 1.5.1.3 -- NRA/Industry Meetings; 1.5.2 -- Patents; 1.5.3 -- Labeling; 1.6 -- The global pharmaceutical industry: harmonization and partnerships; 1.6.1 -- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; 1.6.1.1 -- Scope; 1.6.2 -- Government Regulations: Prospects for Multinational Clinical Trials; 1.6.2.1 -- Pharmaceutical Regulations in Asia. | |
| 505 | 8 | |a 1.7 -- Modernization of the global pharmaceutical systems: regulatory strategies, roadmap initiatives, and partnerships1.7.1 -- The Critical Path Initiative; 1.7.2 -- The European Medicines Agency's Roadmap to 2015; 1.7.3 -- The Progressive Licensing Model of Health Canada; 1.7.4 -- Global Initiatives; 1.7.5 -- World Health Partnerships; References; Chapter 2 -- Trends in Innovation and the Business of Drug Discovery; 2.1 -- Introduction; 2.1.1 -- Pharmaceutical Innovation; 2.1.2 -- The Global Pharmaceutical Business; 2.2 -- Evolutionary trends in pharmaceutical innovation. | |
| 505 | 8 | |a 2.2.1 -- The Global Pharmaceutical Discoveries of the Twentieth Century. | |
| 504 | |a Includes bibliographical references and index. | ||
| 520 | |a This book provides a thorough discussion and analysis of the social factors that affect and influence the drug discovery and development processes, including analysis of important new advances, key scientific and strategic issues, and overviews of recent progress in drug development. | ||
| 650 | 0 | |a Drug development |x Social aspects. | |
| 650 | 2 | |a Drug Discovery |0 (DNLM)D055808 | |
| 650 | 6 | |a M�edicaments |0 (CaQQLa)201-0306620 |x D�eveloppement |0 (CaQQLa)201-0306620 |x Aspect social. |0 (CaQQLa)201-0374080 | |
| 650 | 7 | |a MEDICAL |x Pharmacology. |2 bisacsh | |
| 700 | 1 | |a Rizvi, Syed Abbas, |e author. | |
| 776 | 0 | 8 | |i Print version: |a Osakwe, Odilia. |t Social Aspects of Drug Discovery, Development and Commercialization. |d Saint Louis : Elsevier Science, �2016 |z 9780128022207 |
| 856 | 4 | 0 | |u https://sciencedirect.uam.elogim.com/science/book/9780128022207 |z Texto completo |