Pharmacovigilance

Pharmacovigilance

by Andrews, Elizabeth B. Mann, Ronald D., (Ronald David)

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Written by an international team of outstanding editors and contributors, Pharmacovigilance, 2 nd Edition is the definitive text on this important subject. The new edition has been completely revised and updated to include the latest theoretical and practical aspects of pharmacovigilance including legal issues, drug regulatory requirements, methods of signal generation, reporting schemes and pharmacovigilance in selected system-organ classes.

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Title Statements

  • Full title :Pharmacovigilance / editors, Ronald D. Mann, Elizabeth B. Andrews.

Summary

Written by an international team of outstanding editors and contributors, Pharmacovigilance, 2 nd Edition is the definitive text on this important subject. The new edition has been completely revised and updated to include the latest theoretical and practical aspects of pharmacovigilance including legal issues, drug regulatory requirements, methods of signal generation, reporting schemes and pharmacovigilance in selected system-organ classes.

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Edition Statements

  • Publication Date:©2007.
  • Edition:2nd ed

Publication Statements

  • Publisher(s):John Wiley & Sons
  • Place of Publication:Chichester, England
  • Language:eng
  • Publication Date:©2007.

The Physical Object

  • Description:1 online resource (xviii, 686 pages, 2 unnumbered pages of plates) : : illustrations (some color)

Edition Identifiers

  • ISBN:9780470059210, 0470059214, 9780470059227, 0470059222, 9780470018033, 0470018038
  • DOI:10.1002/9780470059210
  • oclc:ocm86284190
  • LC Classification:RM302.5
  • Dewey Decimal:363.19/463

Table of Contents

Pharmacovigilance; Contents; Contributors; Preface; Foreword; Part I. The Basis of Pharmacovigilance; 1. Introduction; 2. Legal Basis -- EU; 3. Legal Basis -- United States; 4. Ethical Oversight, Consent and Confidentiality; 5. Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation; 6. Periodic Safety Update Reports; 7. Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials; 8. Mechanisms of Adverse Drug Reactions; 9. Micturin and Torsades de Pointes; 10. Withdrawal of Terodiline: A Tale of Two Toxicities.

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Subjects

Drug Monitoring Drug-Related Side Effects and Adverse R… Drug-Related Side Effects and Adverse R… Drugs -- Side effects HEALTH & FITNESS -- Safety Médicaments -- Effets secondaires Pharmacoépidémiologie Pharmacoepidemiology Pharmacoepidemiology -- methods Pharmacovigilance Product Surveillance, Postmarketing

Writers

Andrews, Elizabeth B. Mann, Ronald D., (Ronald David)

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