Pharmacovigilance

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Ronald D. Mann, Elizabeth B. Andrews
John Wiley & Sons, Feb 6, 2007 - Medical - 702 pages
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Written by an international team of outstanding editors and contributors, Pharmacovigilance, 2nd 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. . 
  • The editors and contributors are of excellent standing within the pharmacovigilance community
  • The text provides exemplary coverage of all the relevant issues
  • The definitive book on the subject
 

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Contents

1 Introduction
3
2 Legal Basis EU
13
3 Legal Basis United States
25
4 Ethical Oversight Consent and Confidentiality
35
5 PharmacovigilanceRelated Topics at the Level of the International Conference on Harmonisation
51
6 Periodic Safety Update Reports
63
7 NonClinical Safety Evaluation and Adverse Events in Phase I Trials
75
8 Mechanisms of Adverse Drug Reactions
85
30 Surveillance for Medical Devices USA
375
31 Pharmacovigilance and Risk Management in Japan
387
Part III Pharmacovigilance and Selected System Organ Classes
395
32 Dermatological ADRs
397
33 Gastrointestinal ADRs
407
34 Haematological ADRs
419
35 Hepatic ADRs
429
36 Ocular Side Effects of Prescription Medications
445

9 Micturin and Torsades de Pointes
105
10 Withdrawal of Terodiline A Tale of Two Toxicities
109
11 Nomifensine and Haemolytic Anaemia
137
Part II Signal Generation
149
12 WHO Programme Global Monitoring
151
13 Medical Dictionary for Regulatory Activities MedDRA
167
14 Regulatory Pharmacovigilance in the EU
185
15 Spontaneous Reporting UK
199
16 Spontaneous Reporting France
217
17 Spontaneous Reporting in Germany
227
18 Spontaneous Reporting United States
237
19 Statistical Methods of Signal Detection
249
20 Statistical Methods of Evaluating Pharmacovigilance Data
257
21 Data Mining in Pharmacovigilance A View from the Uppsala Monitoring Centre
265
22 Pharmacovigilance in the Netherlands
277
23 CIOMS Working Groups and their Contribution to Pharmacovigilance
287
24 PEM in the UK
307
25 PEM in New Zealand
317
26 MEMO in the United Kingdom
333
27 The General Practice Research Database Now and the Future
341
28 Overview of North American Databases
349
29 Other Databases in Europe for the Analytic Evaluation of Drug Effects
361
37 Drug Safety in Pregnancy
455
38 Renal Adverse Drug Reactions
467
39 Anaesthetic Adverse Drug Reactions
475
40 Pharmacovigilance in Pediatrics
497
41 The Cardiovascular Spectrum of Adverse Drug Reactions
507
42 Drugs and the Elderly
515
Part IV Key Current Topics
533
43 US Activities in Risk Management of Pharmaceutical Products
535
44 Risk Management a European Regulatory View
553
45 The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents
559
46 Pharmacoepidemiology of Hormone Therapy An Evolving Picture
571
47 NSAIDs COX2 Inhibitors Risks and Benefits
583
48 Introduction to Pharmionics The Vagaries in Ambulatory Patients Adherence to Prescribed Drug Dosing Regimens and Some of Their Clinical an...
603
Part V Lessons and Directions
619
49 Teaching and Learning Pharmacovigilance
621
49b Practical Experience in Teaching Pharmacovigilance
633
50 Fatal Medication Errors and Adverse Drug Reactions Coroners Inquests and Other Sources
635
51 Pharmacogenetics and the Genetic Basis of ADRs
647
52 Keynote Clinical Lessons from Pharmacovigilance
667
Index
677
Plates
687
Copyright

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About the author (2007)

Ronald D. Mann, Professor Emeritus, University of Southampton, UK. 

Elizabeth B. Andrews, RTI Health Solutions, Research Triangle Institute, UNC School of Public Health and School of Pharmacy, NC, USA

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