Stephens' Detection of New Adverse Drug Reactions, Fifth Edition

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 surveillanceContent:
  Chapter 1 Introduction (pages 1–90): Dr Myles Stephens
  Chapter 2 Adverse Drug Reactions and Interactions: Mechanisms, Risk Factors, Detection, Management and Prevention (pages 91–125): Professor P. A. Routledge
  Chapter 3 Toxicology and Adverse Drug Reactions (pages 127–166): Dr D. J. Snodin
  Chapter 4 Clinical Trials: – Collection of Safety Data and Establishing the Adverse Drug Reaction Profile (pages 167–242): Dr J. Talbot and Dr M. D. B. Stephens
  Chapter 5 Clinical Laboratory Safety Data in Drug Studies (pages 243–300): Dr A. Craig
  Chapter 6 Statistics: Analysis and Presentation of Safety Data (pages 301–328): Professor S. J. W. Evans
  Chapter 7 Causality and Correlation in Pharmacovigilance (pages 329–343): Professor S. A. W. Shakir
  Chapter 8 Managing Drug Safety Issues with Marketed Products (pages 345–374): Dr P. C. Waller and Dr H. H. Tilson
  Chapter 9 Regulatory Aspects of Pharmacovigilance (pages 375–451): Dr B. D. C. Arnold
  Chapter 10 Legal Aspects of Pharmacovigilance (pages 453–491): C. Bendall
  Chapter 11 Operational Aspects of the Drug Safety Function within a Pharmaceutical Company (pages 493–532): Professor Janet Steiner
  Chapter 12 Dictionaries and Coding in Pharmacovigilance (pages 533–557): Dr E. G. Brown
  Chapter 13 Safety of Biotechnology Products (pages 559–569): Dr B. Brown and Dr M. Westland
  Chapter 14 Vaccine Safety Surveillance (pages 571–590): Dr E. Miller
  Chapter 15 Ethical Issues in Drug Safety (pages 591–648): Dr M. D. B. Stephens
  Chapter 16 A Model for the Future Conduct of Pharmacovigilance (pages 649–666): Dr P. C. Waller and Professor S. J. W. Evans