Pharmacovigilance /
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| Edition: | 2nd ed. |
|---|---|
| Imprint: | Chichester, England ; Hoboken, NJ : John Wiley & Sons, c2007. |
| Description: | xviii, 686 p., [2] p. of plates : ill. (some col.) ; 26 cm. |
| Language: | English |
| Subject: | |
| Format: | Print Book |
| URL for this record: | http://pi.lib.uchicago.edu/1001/cat/bib/6326678 |
Table of Contents:
- List of Contributors
- Preface
- Foreword
- Part I. Basis of Pharmacovigilance
- Introduction
- Legal Basis-EU
- Legal Basis-US
- Ethical Oversight, Consent and Confidentiality
- Pre-clinical Safety Evaluation
- Metabolic Mechanisms
- Drugs and the Elderly
- Natural History
- Responding to Signals
- Micturin and Torsades de Pointes
- Withdrawal of Terodiline: A Tale of Two Toxicities
- Nomifensine and Haemolytic Anaemia
- Part II. Signal Generation
- WHO Programme-Global Monitoring
- Regulatory Pharmacovigilance in the EU
- Spontaneous Reporting-UK
- Spontaneous Reporting-France
- Spontaneous Reporting-USA
- Algorithms
- Overview-Spontaneous Signalling
- Statistical Methods of Signal Detection
- Statistical Methods of Evaluating Pharmacovigilance Data
- Data Mining
- Epidemiology of Adverse Events Associated with Epilepsy and Use of Lamotrigine
- Pharmacovigilance in the Netherlands
- CIOMS Working Groups and their Contribution to Pharmacovigilance
- PEM in the UK
- PEM in New Zealand
- MEMO in the UK
- GPRD in the UK
- Overview of North American Databases
- Pharmacovigilance in the HMO Research Network
- Other Databases in Europe
- Surveillance for Medical Devices-USA
- Part III. Pharmacovigilance and Selected System Organ Classes
- Dermatological ADRs
- Gastrointestinal ADRs
- Haematological ADRs
- Hepatic Adverse Drug Reactions
- Ocular ADRs
- Drug Safety in Pregnancy
- ADRs and Drug Safety 1999-2000
- Part IV. Lessons and Directions
- Teaching Pharmacovigilance
- Medical Errors and Lessons from Drug-Related Deaths
- Pharmacogenetics and the Genetic Basis of ADRs
- Keynote Clinical Lessons from Pharmacovigilance
- Index
