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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, in-depth, 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.