John Talbot & Patrick Waller 
Stephens’ Detection of New Adverse Drug Reactions 

A key text for all those involved in pharmacovigilance.

Detection of new adverse drug reactions is fundamental to the protection of patients from harm that may occur as a result of medication. This book explores the methods used to investigate new adverse drug reactions, discussing all elements from the scientific background and animal toxicology through to worldwide regulatory and ethical issues.

Stephens’ Detection of New Adverse Drug Reactions provides comprehensive and up-to-date coverage of material fundamentally important to all those active in the field, whether they work in the pharmaceutical industry, drug regulatory authorities or in academia.

The fifth edition of this classic reference work includes new chapters on:

* vaccine safety surveillance

* managing drug safety issues with marketed products

* operational aspects of drug safety function

* safety of biotechnology products

* future of pharmacovigilance

Reviews of previous editions:

‘This book surpasses all its educational aims. Not only is the subject matter covered comprehensively but the material is presented in a very user-friendly manner. The editors have succeeded in producing a highly-specific, definitive reference book which doubles as a most enjoyable read.’ Commended by the 1999 BMA Medical Book Competition

‘For anyone entering the field of adverse reaction monitoring one could not wish for a better primer’ International Journal of Risk and Safety in Medicine

Table of Content

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.

About the author

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.