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Informationen zum Autor John Talbot, Senior Lecturer, University of Hertfordshire, UK. Formerly Director, Global Drug Safety, AstraZeneca R&D Charnwood, Loughborough, Leicestershire, UK Jeffrey Aronson, Reader in Clinical Pharmacology, University of Oxford, Oxford, UK and President Emeritus of the British Pharmacological Society Klappentext The detection and evaluation of adverse drug reactions is crucial for understanding the safety of medicines and for preventing harm in patients. Not only is it necessary to detect new adverse drug reactions, but the principles and practice of pharmacovigilance apply to the surveillance of a wide range of medicinal products.Stephens' Detection and Evaluation of Adverse Drug Reactions provides a comprehensive review of all aspects of adverse drug reactions throughout the life cycle of a medicine, from toxicology and clinical trials through to pharmacovigilance, risk management, and legal and regulatory requirements. It also covers the safety of biotherapeutics and vaccines and includes new chapters on pharmacogenetics, proactive risk management, societal considerations, and the safety of drugs used in oncology and herbal medicines.This sixth edition of the classic text on drug safety is an authoritative reference text for all those who work in pharmacovigilance or have an interest in adverse drug reactions, whether in regulatory authorities, pharmaceutical companies, or academia.Praise for previous editions"This book presents a comprehensive and wide-ranging overview of the science of pharmacovigilance. For those entering or already experienced in the pharmaceutical sciences, this is an essential work." - from a review in E-STREAMS"...a key text in the area of pharmacovigilance...extensively referenced and well-written...a valuable resource..." - from a review in The Pharmaceutical Journal Zusammenfassung Written with practitioners in mind, this new edition of Stephen s Detection of Adverse Drug Reactions: Principle and Practice continues to be one of the corner stones of the pharmaceutical medicine list. Inhaltsverzeichnis Foreword xi Preface to the Sixth Edition xiii List of Contributors xv Acknowledgements xvii 1 Adverse Drug Reactions: History, Terminology, Classification, Causality, Frequency, Preventability 1 Jeffrey K. Aronson 1.1 Introduction 1 1.2 Defining pharmacovigilance 1 1.3 The modern history of pharmacovigilance 3 1.4 Terminology and definitions in pharmacovigilance 6 1.5 Medication errors 25 1.6 Pharmacological classification of adverse drug reactions 32 1.7 Drug interactions 53 1.8 Reporting suspected adverse drug reactions 59 1.9 Causality assessment 64 1.10 Frequencies of adverse drug reactions 69 1.11 Risk perception and adverse drug reactions 77 1.12 Class effects of drugs 78 1.13 Unlicensed indications, off-label uses, and orphan drugs 80 1.14 Preventing adverse drug reactions 84 1.15 Publishing accounts of adverse drug reactions 95 References 101 2 Pharmacogenetics of Adverse Drug Reactions 121 Sudeep P. Pushpakom and Munir Pirmohamed 2.1 Introduction 121 2.2 Historical review 121 2.3 Sources of genetic variability 122 2.4 Role of pharmacogenetic factors in drug pharmacokinetics 123 2.5 Role of pharmacogenetic factors in drug pharmacodynamics 133 2.6 The role of pharmacogenetics in pharmaceutical companies 139 2.7 The impact of pharmacogenetics on regulatory agencies 141 2.8 The impact of pharmacogenetics on clinical practice 143 2.9 Conclusions 145 References 145 3 Toxicology and Adverse Drug Reactions 157 D. J. Snodin and A. Suitters 3.1 Introduction 157 3.2 Toxicity testing 157 ...
