Regulation of the Pharmaceutical Industry (Studies in Regulation)

Abraham, John (EDT)/ Smith, Helen Lawton/ Lawton Smith, Helen (EDT)

Palgrave Macmillan（2003/07発売）

• 製本 Hardcover:ハードカバー版／ページ数 256 p.
• 言語 ENG
• 商品コード 9780333790441
• DDC分類 338

基本説明

Publication delayed (Originally scheduled in December 2000). This is a unique collection bringing together the work of social scientists and policy analysts on the regulation of the pharmaceutical industry.

Full Description

How are pharmaceutical technologies developed and controlled in our societies? To what extent should the availability of these technologies be determined by scientific experts, a democratic state, the interests of final users, or ethical principles? This unique collection brings together the work of social scientists, ethicists, lawyers and policy analysts on regulation, ethics and innovation in the pharmaceutical industry. Regulatory systems and their implications for public health in North America, Europe and developing countries are discussed, including case studies of norplant, interferon and anti-fertility vaccines.

Contents

List of Tables and Figures Notes on the Contributors Acknowledgements Introduction; J.Abraham Regulatory Laws and Political Culture in the United States and Germany; A.Daemmrich Europeanization of Medicines Regulation; J.Abraham & G.Lewis Globalization of Medicines Control; J.Abraham & T.Reed Sales Licensing Documentation and Trade Secrecy: The Case of Norplant Contraceptives; E.Ollila & E.Hemminki Biological Medicines in the Age of Biotech: Public Policy Issues; N.Morris New Molecules, Markets and Changing Drug Regulatory Practices; T.Peters Users' Involvement in Regulating Contraceptive Innovation: The Design of Anti-Fertility Vaccines; J.van Kammen Regulations for Ethical Purposes: Medical Research on Humans; C.Foster The Limitations of Current Ethical Regulations; O.Corrigan Mergers and Joint Ventures in the Pharmaceutical Industry; H.Kelly & M.Hadden