Pharmacovigilance

Title Statements

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

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:xviii, 686 pages, 2 unnumbered pages of plates : : illustrations (some color) ; : 26 cm

Edition Identifiers

ISBN:9780470018033, 0470018038
oclc:ocm70881755
LC Classification:RM302.5
Dewey Decimal:363.19/463

Contributors.Preface.Foreword.PART I. THE BASIS OF PHARMACOVIGILANCE.1. Introduction (Ronald D. Mann and Elizabeth B. Andrews).2. Legal Basis -- EU (Nicholas Macfarlane, Paul Brown, Caroline Moore, Claire Taylor,Uwe Froehlich, Tanja Barton, Olivier Banchereau and Paola La Licata).3. Legal Basis -- United States (Jayne P. Bultena).4. Ethical Oversight, Consent and Confidentiality (Donna A. Boswell and Elizabeth B. Andrews).5. Pharmacovigilance-Related Topics at the Level of the International Conference onHarmonisation (Priya Bahri and Panos Tsintis).6. Periodic Safety Update Reports (Patrice Verpillat and Mondher Toumi).7. Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials (Patricia M. Reed, Stuart J. Mair and Stephen Freestone).8. Mechanisms of Adverse Drug Reactions (Munir Pirmohamed and B. Kevin Park).9. Micturin and Torsades de Pointes (Richard N. Wild).10. Withdrawal of Terodiline: A Tale of Two Toxicities (Rashmi R. Shah).11. Nomifensine and Haemolytic Anaemia (Peter D. Stonier and J. Guy Edwards).PART II. SIGNAL GENERATION.12. WHO Programme -- Global Monitoring (I. Ralph Edwards and Cecilia Biriell).13. Medical Dictionary for Regulatory Activities (MedDRA(r)…

Subjects

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