Stephens' detection and evaluation of adverse drug reactions: principles and practice

INDICE: Foreword Preface to the Sixth Edition List of Contributors Acknowledgements 1 Adverse Drug Reactions: History, Terminology, Classification, Causality, Frequency, Preventability Jeffrey K. Aronson 1.1 Introduction 1.2 Defining pharmacovigilance 1.3 The modern history of pharmacovigilance 1.4 Terminology and definitions in pharmacovigilance 1.5 Medication errors 1.6 Pharmacological classification of adverse drug reactions 1.7 Drug interactions 1.8 Reporting suspected adverse drug reactions 1.9 Causality assessment 1.10 Frequencies of adverse drug reactions 1.11 Risk perception and adverse drug reactions 1.12Class effects of drugs 1.13 Unlicensed indications, off-label uses, and orphan drugs 1.14 Preventing adverse drug reactions 1.15 Publishing accounts of adverse drug reactions References 2 Pharmacogenetics of Adverse Drug Reactions Sudeep P. Pushpakom and Munir Pirmohamed 2.1 Introduction 2.2 Historical review 2.3 Sources of genetic variability 2.4 Role of pharmacogenetic factors in drugpharmacokinetics 2.5 Role of pharmacogenetic factors in drug pharmacodynamics2.6 The role of pharmacogenetics in pharmaceutical companies 2.7 The impact of pharmacogenetics on regulatory agencies 2.8 The impact of pharmacogenetics on clinical practice 2.9 Conclusions References 3 Toxicology and Adverse Drug Reactions D. J. Snodin and A. Suitters 3.1 Introduction 3.2 Toxicity testing 3.3 Drug discovery and development 3.4 Data interpretation and risk assessment 3.5 Adverse drug reactions detected after marketing authorization 3.6 Examples of toxicological investigation of ADRs 3.7 Conclusions Acknowledgements References 4 Clinical TrialsCollecting Safety Data and Establishing the Adverse DrugReactions Profile John Talbot, Marianne Keisu, and Lars St°ahle 4.1 Introduction 4.2 Adverse events 4.3 Clinical studies and safety 4.4 The emerging safetyprofile 4.5 Presentation of safety data 4.6 Conclusions References 5 ClinicalLaboratory Safety Data Alan Craig 5.1 Introduction 5.2 Factors that influencethe interpretation of clinical laboratory data 5.3 Sample collection procedure 5.4 Analytical variation 5.5 Reference ranges 5.6 Intra-individual biological variation 5.7 Detecting adverse events during drug development 5.8 Test selection 5.9 Exclusion criteria and panic levels 5.10 Harmonization of data from different laboratories 5.11 Data analysis and presentation 5.12 Conclusions 5.13 Appendix References 6 Statistics: Analysis and Presentation of Safety Data Stephen J. W. Evans and Dorothea Nitsch 6.1 Introduction and background 6.2 Problems with efficacy trials for detecting adverse drug reactions 6.3 Analysis and presentation of data from trials 6.4 Statistical measures of the occurrence of adverse events 6.5 Combining data from several trialsmeta-analysis 6.6 Use of statistical methods for signal detection from spontaneous reports 6.7 Analysis and presentation of data from observational studies 6.8 Summary and conclusions Acknowledgements References 7 Proactive

• ISBN: 978-0-470-98634-9
• Editorial: John Wiley & Sons
• Encuadernacion: Cartoné
• Páginas: 752
• Fecha Publicación: 23/12/2011
• Nº Volúmenes: 1
• Idioma: Inglés