Written by multidisciplinary experts in the fields of pharmaceutical and patient safety, Pharmacovigilance: A Practical Approach, Second Edition, provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. From cover to cover, this concise resource offers essential information for physicians and other health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.
1. Introduction - p. xi 2. Contents - p. xii 3. Section 1 The Regulatory Environment and the Pharmacovigilance Quality System - p. p1 4. Chapter 1 Does Regulation Drive Science or Does Science Drive Regulation? - p. 1 5. Section 2 Preclinical Safety Assessment - p. p13 6. Chapter 2 Absorption, Distribution, Metabolism and Excretion, Pharmacokinetics, and Safety Pharmacology - p. 13 7. Chapter 3 Preclinical Safety Assessment: General and Genetic Toxicology - p. 23 8. Chapter 4 Pharmacogenetics - p. 31 9. Section 3 First-In-Human Trials - p. p43 10. Chapter 5 Safety Planning for First-in-Human Trials - p. 43 11. Chapter 6 Pharmacokinetic and Pharmacodynamic Considerations in Safety Evaluation - p. 49 12. Section 4 Safety Assessment in Clinical Trials - p. p57 13. Chapter 7 Safety Monitoring in Clinical Trials - p. 57 14. Chapter 8 Introduction to Quantitative Methods and Visual Analytics in Drug Safety Data in Clinical Trials - p. 72 15. Chapter 9 Product Aggregate Safety Assessment - p. 83 16. Chapter 10 Data Monitoring Committees - p. 92 17. Section 5 Signal and Risk Management - p. p104 18. Chapter 11 Methods of Signal Detection and Signal Management - p. 104 19. Chapter 12 Causality Assessment - p. 121 20. Chapter 13 Examples of Adverse Drug Reactions: Drug-Induced Liver Injury, Renal, Skin, Immune-Mediated Events, and Major Adverse Cardiac Events - p. 127 21. Chapter 14 Internal Safety Advisory Groups - p. 148 22. Chapter 15 Benefit–Risk Management - p. 154 23. Section 6 Role of Epidemiology and Realworld Evidence - p. p172 24. Chapter 16 Role of Epidemiology and Pharmacoepidemiology in the Biopharmaceutical Industry - p. 172 25. Chapter 17 Real-World Pharmacoepidemiology Studies - p. 187 26. Section 7 Special Populations and Special Topics - p. p201 27. Chapter 18 Pharmacovigilance in Pregnancy - p. 201 28. Chapter 19 Pharmacovigilance in Pediatrics - p. 218 29. Chapter 20 Pharmacovigilance in the Elderly - p. 226 30. Chapter 21 Vaccine Pharmacovigilance - p. 233 31. Chapter 22 Application of Human Factors and Health Literacy in Pharmacovigilance - p. 245 32. Chapter 23 Medical Device Safety Oversight and Surveillance - p. 249 33. Section 8 The Next Frontier - p. p262 34. Chapter 24 Information Technology in Pharmacovigilance: Current State and Future Directions - p. 262 35. Chapter 25 The Future of Pharmacovigilance - p. 276 36. Index - p. 283
Written by multidisciplinary experts in the fields of pharmaceutical and patient safety, Pharmacovigilance: A Practical Approach, Second Edition, provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. From cover to cover, this concise resource offers essential information for physicians and other health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.
1. Introduction - p. xi 2. Contents - p. xii 3. Section 1 The Regulatory Environment and the Pharmacovigilance Quality System - p. p1 4. Chapter 1 Does Regulation Drive Science or Does Science Drive Regulation? - p. 1 5. Section 2 Preclinical Safety Assessment - p. p13 6. Chapter 2 Absorption, Distribution, Metabolism and Excretion, Pharmacokinetics, and Safety Pharmacology - p. 13 7. Chapter 3 Preclinical Safety Assessment: General and Genetic Toxicology - p. 23 8. Chapter 4 Pharmacogenetics - p. 31 9. Section 3 First-In-Human Trials - p. p43 10. Chapter 5 Safety Planning for First-in-Human Trials - p. 43 11. Chapter 6 Pharmacokinetic and Pharmacodynamic Considerations in Safety Evaluation - p. 49 12. Section 4 Safety Assessment in Clinical Trials - p. p57 13. Chapter 7 Safety Monitoring in Clinical Trials - p. 57 14. Chapter 8 Introduction to Quantitative Methods and Visual Analytics in Drug Safety Data in Clinical Trials - p. 72 15. Chapter 9 Product Aggregate Safety Assessment - p. 83 16. Chapter 10 Data Monitoring Committees - p. 92 17. Section 5 Signal and Risk Management - p. p104 18. Chapter 11 Methods of Signal Detection and Signal Management - p. 104 19. Chapter 12 Causality Assessment - p. 121 20. Chapter 13 Examples of Adverse Drug Reactions: Drug-Induced Liver Injury, Renal, Skin, Immune-Mediated Events, and Major Adverse Cardiac Events - p. 127 21. Chapter 14 Internal Safety Advisory Groups - p. 148 22. Chapter 15 Benefit–Risk Management - p. 154 23. Section 6 Role of Epidemiology and Realworld Evidence - p. p172 24. Chapter 16 Role of Epidemiology and Pharmacoepidemiology in the Biopharmaceutical Industry - p. 172 25. Chapter 17 Real-World Pharmacoepidemiology Studies - p. 187 26. Section 7 Special Populations and Special Topics - p. p201 27. Chapter 18 Pharmacovigilance in Pregnancy - p. 201 28. Chapter 19 Pharmacovigilance in Pediatrics - p. 218 29. Chapter 20 Pharmacovigilance in the Elderly - p. 226 30. Chapter 21 Vaccine Pharmacovigilance - p. 233 31. Chapter 22 Application of Human Factors and Health Literacy in Pharmacovigilance - p. 245 32. Chapter 23 Medical Device Safety Oversight and Surveillance - p. 249 33. Section 8 The Next Frontier - p. p262 34. Chapter 24 Information Technology in Pharmacovigilance: Current State and Future Directions - p. 262 35. Chapter 25 The Future of Pharmacovigilance - p. 276 36. Index - p. 283
