Stephens' Detection of New Adverse Drug Reactions is key for all those involved in pharmacovigilance.

This reference volume 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.

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

Stephens' Detection of New Adverse Drug Reactions provides comprehensive, in-depth, up-to-date coverage of material fundamentally important to all those active in the field.

Contents

1. Introduction
2. Adverse Drug Reaction and Interactions: Mechanisms, Risk Factors, Detection, Management and Prevention
3. Toxicology and Adverse Drug Reactions
4. Clinical Trials: Collection of Safety Data and Establishing the Adverse Drug Reaction Profile
5. Clinical Laboratory Safety Data in Drug Studies
6. Statistics: Analysis and Presentation of Safety Data
7. Causality and Correlation in Pharmacovigilance
8. Managing Drug Safety Issues with Marketed Products
9. Regulatory Aspects of Pharmacovigilance
10. Legal Aspects of Pharmacovigilance
11. Operational Aspects of the Drug Safety Function within a Pharmaceutical Company
12. Dictionaries and Coding in Pharmacovigilance
13. Safety of Biotechnology Products
14. Vaccine Safety Surveillance
15. Ethical Issues in Drug Safety
16. A Model for the Future Conduct of Pharmacovigilance

Appendices
Index

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