Stephens' Detection of New Adverse Drug Reactions, 5th EditionISBN: 978-0-470-84552-3
Hardcover
762 pages
March 2004
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Foreword.
Preface.
List of Contributors.
1. Introduction (M. Stephens).
2. Adverse Drug Reaction and Interactions: Mechanisms, Risk Factors, Detection, Management and Prevention (P. Routledge).
3. Toxicology and Adverse Drug Reactions (D. Snodin).
4. Clinical Trials: Collection of Safety Data and Establishing the Adverse Drug Reaction Profile (J. Talbot & M. Stephens).
5. Clinical Laboratory Safety Data in Drug Studies (A. Craig).
6. Statistics: Analysis and Presentation of Safety Data (S. Evans).
7. Causality and Correlation in Pharmacovigilance (S. Shakir).
8. Managing Drug Safety Issues with Marketed Products (P. Waller & H. Tilson).
9. Regulatory Aspects of Pharmacovigilance (B. Arnold).
10. Legal Aspects of Pharmacovigilance (C. Bendall).
11. Operational Aspects of the Drug Safety Function within a Pharmaceutical Company (J. Steiner).
12. Dictionaries and Coding in Pharmacovigilance (E. Brown).
13. Safety of Biotechnology Products (B. Brown and M. Westland).
14. Vaccine Safety Surveillance (E. Miller).
15. Ethical Issues in Drug Safety (M. Stephens).
16. A Model for the Future Conduct of Pharmacovigilance (P. Waller and S. Evans).
Appendix I.
Appendix II.
Bibliography.
Index.
Preface.
List of Contributors.
1. Introduction (M. Stephens).
2. Adverse Drug Reaction and Interactions: Mechanisms, Risk Factors, Detection, Management and Prevention (P. Routledge).
3. Toxicology and Adverse Drug Reactions (D. Snodin).
4. Clinical Trials: Collection of Safety Data and Establishing the Adverse Drug Reaction Profile (J. Talbot & M. Stephens).
5. Clinical Laboratory Safety Data in Drug Studies (A. Craig).
6. Statistics: Analysis and Presentation of Safety Data (S. Evans).
7. Causality and Correlation in Pharmacovigilance (S. Shakir).
8. Managing Drug Safety Issues with Marketed Products (P. Waller & H. Tilson).
9. Regulatory Aspects of Pharmacovigilance (B. Arnold).
10. Legal Aspects of Pharmacovigilance (C. Bendall).
11. Operational Aspects of the Drug Safety Function within a Pharmaceutical Company (J. Steiner).
12. Dictionaries and Coding in Pharmacovigilance (E. Brown).
13. Safety of Biotechnology Products (B. Brown and M. Westland).
14. Vaccine Safety Surveillance (E. Miller).
15. Ethical Issues in Drug Safety (M. Stephens).
16. A Model for the Future Conduct of Pharmacovigilance (P. Waller and S. Evans).
Appendix I.
Appendix II.
Bibliography.
Index.
Related Titles
General Pharmacology & Pharmaceutical Medicine
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