The Textbook of Pharmaceutical Medicine

Detalles Bibliográficos
Autor principal: Griffin, John P.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Newark : John Wiley & Sons, Incorporated, 2006.
Colección:New York Academy of Sciences Ser.
Temas:
Electronic books.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • The Textbook of Pharmaceutical Medicine
  • Contents
  • Contributors
  • Preface
  • Acknowledgements
  • The Editors
  • PART I: Research and development
  • 1. Discovery of new medicines
  • 2. Pharmaceutical development
  • 3. Preclinical safety testing
  • 4. Exploratory development
  • 5. Clinical pharmacokinetics
  • 6. Purpose and design of clinical trials
  • 7. Conduct of clinical trials: good clinical practice
  • 8. Medical statistics
  • 9. Development of medicines: full development
  • PART II: Medical department issues
  • 10. The medical department
  • 11. Medical marketing
  • 12. Information and promotion
  • 13. The supply of unlicensed medicines for particular patient use
  • 14. Legal and ethical issues relating to medicinal products
  • 15. The safety of medical products
  • PART III: Regulatory aspects
  • 16. History of drug egulation in the United Kingdom
  • 17. Regulation of human medicinal products in the European Union
  • 18. European regulation of medical devices
  • 19. Technical requirements for registration of pharmaceuticals for human use: the ICH process
  • 20. The regulation of drug products by the United States Food and Drug Administration
  • 21. The US FDA in the drug development,evaluation and approval process
  • 22. Past evolution and future prospects of the Pharma Industry and its regulation in the USA
  • 23. Regulatory and clinical trial systems in Japan
  • 24. The regulation of therapeutic products in Australia
  • PART IV: Pharmacoeconomic and other issues
  • 25. Economics of healthcare
  • 26. Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective) with some international comparisons
  • Appendix 1: Declaration of Helsinki
  • Appendix 2: Code of Practice for the Pharmaceutical Industry
  • Appendix 3: Guidelines and Documentation for Implementation of Clinical Trials
  • Appendix 4: Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001
  • Index

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