Stephens' Detection of New Adverse Drug ReactionsJohn Talbot, Patrick Waller 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 |
Contents
2 Adverse Drug Reactions and Interactions Mechanisms Risk Factors Detection Management and Prevention | 91 |
3 Toxicology and Adverse Drug Reactions | 127 |
4 Clinical Trials Collection of Safety Data and Establishing the Adverse Drug Reaction Profile | 167 |
5 Clinical Laboratory Safety Data in Drug Studies | 243 |
6 Statistics Analysis and Presentation of Safety Data | 301 |
7 Causality and Correlation in Pharmacovigilance | 329 |
8 Managing Drug Safety Issues with Marketed Products | 345 |
9 Regulatory Aspects of Pharmacovigilance | 375 |
12 Dictionaries and Coding in Pharmacovigilance | 533 |
13 Safety of Biotechnology Products | 559 |
14 Vaccine Safety Surveillance | 571 |
15 Ethical Issues in Drug Safety | 591 |
16 A Model for the Future Conduct of Pharmacovigilance | 649 |
Appendix I | 667 |
Appendix II | 703 |
Bibliography | 707 |
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Common terms and phrases
ADR reporting ADRs adverse drug reactions adverse events adverse reactions analysis assessment associated bilirubin causality cause cell cent CIOMS Clin Pharmacol clinical trials CPMP database detection disease dose drug safety efficacy enzyme EudraVigilance evaluation evidence example expedited reporting factors guidelines hepatitis hormone hospital important incidence increased individual International investigational products investigator laboratory Lancet liver marketing measures MedDRA1 medicinal products metabolism method MMR vaccine monitoring myocardial infarction normal occur patients period pharmaceutical companies pharmaceutical industry Pharmacoepidemiology pharmacokinetic pharmacological pharmacovigilance phase physicians placebo possible post-marketing potential prescribing protein PSUR questionnaire reference range Regulation regulatory authorities relevant renal response risk safety data safety issues serious AEs serious unexpected significant specific sponsor spontaneous reporting standard statistical studies symptoms Table tests therapeutic therapy toxicity toxicological treatment Uppsala Monitoring Centre vaccine