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Pharmacovigilance is the study of the safety of marketed drugs under practical conditions of clinical usage in large communities. This book describes the current theory and practice. The subject falls into categories: The Basis of Pharmacovigilance (legal, ethical, methodological); Signal Generation (reporting of Adverse Drug Reactions from individuals to countries); Pharmacovigilance and Selected System Organ Classes (eg. How ADRs are seen in the skin, gut etc.); Key Current Topics (eg. HRT, Risks and Benefits) and Lessons and Directions (when things go wrong). This new edition reduces amount of historical information, increases coverage on numbers of countries on Signal reporting to include Germany and Japan (two large/important areas), and make the Organ Classes section comprehensive (not possible last time) as well as adding Current Topics to give a state of the art impression.
John Wiley and Sons Ltd
January 26, 2007
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