Stephens′ Detection of New Adverse Drug Reactions 5e

JOHN TALBOT is a Senior Lecturer in the School of Allied Health at Anglia Ruskin University in Cambridge, UK, with expertise in MSc Magnetic Resonance Imaging education. PATRICK WALLER has been an independent consultant in pharmacovigilance and pharmacoepidemiology n since 2002. He also holds honorary academic appointments at the London School of Hygiene and Tropical Medicine and the University of Dundee. From 1998-2004 he was Visiting Professor in the Department of Pharmacological Sciences at the University of Newcastle-upon-Tyne. From 1990-2002 he worked in the field of pharmacovigilance for the Medicines Control Agency in London. From 1998-2000 he was one of the UK delegates to the Committee for Proprietary Medicinal Products and Chairman of its Pharmacovigilance Working Party.

Foreword. Preface. List of Contributors. 1. Introduction (M. Stephens). 2. Adverse Drug Reaction and Interactions: Mechanisms, Risk Factors, Detection, Management and Prevention (P. Routledge). 3. Toxicology and Adverse Drug Reactions (D. Snodin). 4. Clinical Trials: Collection of Safety Data and Establishing the Adverse Drug Reaction Profile (J. Talbot & M. Stephens). 5. Clinical Laboratory Safety Data in Drug Studies (A. Craig). 6. Statistics: Analysis and Presentation of Safety Data (S. Evans). 7. Causality and Correlation in Pharmacovigilance (S. Shakir). 8. Managing Drug Safety Issues with Marketed Products (P. Waller & H. Tilson). 9. Regulatory Aspects of Pharmacovigilance (B. Arnold). 10. Legal Aspects of Pharmacovigilance (C. Bendall). 11. Operational Aspects of the Drug Safety Function within a Pharmaceutical Company (J. Steiner). 12. Dictionaries and Coding in Pharmacovigilance (E. Brown). 13. Safety of Biotechnology Products (B. Brown and M. Westland). 14. Vaccine Safety Surveillance (E. Miller). 15. Ethical Issues in Drug Safety (M. Stephens). 16. A Model for the Future Conduct of Pharmacovigilance (P. Waller and S. Evans). Appendix I. Appendix II. Bibliography. Index.