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E-book
Author Osakwe, Odilia, author

Title Social aspects of drug discovery, development and commercialization / Odilia Osakwe, Syed A.A. Rizvi
Published London, UK : Academic Press is an imprint of Elsevier, 2016
Online access available from:
ProQuest Ebook Central    View Resource Record  
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Description 1 online resource
Contents 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
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
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
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
2.2.1 -- The Global Pharmaceutical Discoveries of the Twentieth Century
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
Summary 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
Notes Includes index
Bibliography Includes bibliographical references and index
Notes Online resource; title from PDF title page (ScienceDirect, viewed March 2, 2016)
Subject Drug development -- Social aspects
Drug Discovery
MEDICAL -- Pharmacology.
Form Electronic book
Author Rizvi, Syed Abbas, author
ISBN 0128024976 (electronic bk.)
9780128024973 (electronic bk.)
(print)