About the Book

Stephens'Detection and Evaluation of Adverse Drug Reactions, 6ed: Principles and Practice
This book covers the issues and problems involved in the detection of adverse drug reactions throughout the life cycle of a medicine from animal studies through to clinical trials, market approval, post-market monitoring of clinical use and eventual decline in use or withdrawal. This theme is supported by topics that reach across the life cycle of a drug, such as causality assessment, legal aspects, dictionaries and coding and ethical issues. Written with practitioners in mind, the text is a corner stone of the pharmaceutical medicine list, one of two major works on pharmacovigilance.

About the Author

Stephens'Detection and Evaluation of Adverse Drug Reactions, 6ed: Principles and Practice 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

Table of Contents:
John Talbot, Jeffrey K. Aronson Foreword Preface to the Sixth Edition List of Contributors Acknowledgements 1 Adverse Drug Reactions: History, Terminology, Classification, Causality, Frequency, Preventability 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 1.12 Class 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 2 Pharmacogenetics of Adverse Drug Reactions 2.1 Introduction 2.2 Historical review 2.3 Sources of genetic variability 2.4 Role of pharmacogenetic factors in drug pharmacokinetics 2.5 Role of pharmacogenetic factors in drug pharmacodynamics 2.6 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 3 Toxicology and Adverse Drug Reactions 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 4 Clinical Trials--Collecting Safety Data and Establishing the Adverse Drug Reactions Profile 4.1 Introduction 4.2 Adverse events 4.3 Clinical studies and safety 4.4 The emerging safety profile 4.5 Presentation of safety data 4.6 Conclusions 5 Clinical Laboratory Safety Data 5.1 Introduction 5.2 Factors that influence the 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 6 Statistics: Analysis and Presentation of Safety Data 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 trials--meta-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 7 Proactive Pharmacovigilance and Risk Management 7.1 Introduction 7.2 Risk management--definition and general principles 7.3 Defining the knowledge base--the safety specification 7.4 Extending the knowledge of safety and characterizing risk--the pharmacovigilance plan 7.5 Minimizing risks 7.6 Special challenges for risk management 7.7 Experience with risk evaluation and mitigation strategies (REMS) in the USA 7.8 A possible method for risk management when a new adverse reaction is discovered after marketing 7.9 Future challenges for risk management 7.10 Conclusions 8 Regulatory Aspects of Pharmacovigilance 8.1 Introduction 8.2 The standardization and harmonization of safety data collection and reporting: CIOMS and ICH 8.3 The European Union 8.4 The UK 8.5 France 8.6 Germany 8.7 USA 8.8 Japan 9 Legal Aspects of Pharmacovigilance in the European Union 9.1 Introduction 9.2 Application of EU legislation in Member States 9.3 Interpretation of EU law 9.4 Relationship between law and guidelines 9.5 Issues in interpreting EU pharmacovigilance legislation 9.6 Legal responsibility for pharmacovigilance activities 9.7 Failures to meet pharmacovigilance requirements 9.8 Enforcement and sanctions 9.9 European powers and procedures in the event of a product safety issue 9.10 Civil liability 9.11 Personal data privacy 9.12 Safety in research products 10 Dictionaries and Coding in Pharmacovigilance 10.1 Introduction 10.2 Scope of this chapter 10.3 What is a dictionary? 10.4 Drug dictionaries 10.5 Disease classifications 10.6 Medical Dictionary for Regulatory Activities, MedDRA 10.7 Common Terminology Criteria for Adverse Events (CTCAE) 10.8 Definition of adverse reaction terms 10.9 Dictionaries used in electronic health records 10.10 Use of dictionaries in standard product information 10.11 Conclusions 11 Adverse Drug Reactions: Societal Considerations 11.1 Introduction 11.2 Adverse drug reactions at the population level 11.3 The social production of ADRs 11.4 Trust 11.5 Information about ADRs 11.6 Conclusions 12 Safety of Biotherapeutics 12.1 Introduction 12.2 Properties of proteins 12.3 Classification of biotherapeutics 12.4 Monitoring for adverse events due to biotherapeutics 12.5 Conclusions 13 Vaccine Safety Surveillance 13.1 Introduction 13.2 What is special about vaccine safety compared with other drugs? 13.3 Pathogenesis of vaccine reactions 13.4 Criteria for establishing causality after vaccine-related adverse events 13.5 Pre-licensing evaluation of vaccine safety 13.6 Objectives of an ideal post-licensing vaccine safety surveillance system 13.7 Conclusions 14 Assessing the Safety of Drugs Used in Oncology 14.1 Introduction 14.2 Factors to consider when assessing the safety of drugs used in oncology 14.3 Sources of adverse effect data 14.4 Nature of the data 14.5 Assessment of adverse effects data in oncology 14.6 Conclusions 15 Adverse Drug Reactions and Pharmacovigilance of Herbal Medicines 15.1 Introduction 15.2 Herbal medicines: definitions and descriptions 15.3 Characteristics of herbal medicines 15.4 Regulation of herbal medicines and pharmacovigilance requirements 15.5 Access to and use of herbal medicines 15.6 Adverse reactions associated with herbal medicines 15.7 Methods for pharmacovigilance of herbal medicines 15.8 Responding to safety concerns associated with herbal medicines 15.9 The future for pharmacovigilance of herbal medicines 15.10 Conclusions Appendix 1 Web Sites Relevant to Pharmacovigilance--An Analysis of Contents Appendix 2 Guidelines and a Checklist for Reporting Suspected Adverse Drug Reactions Anecdotally in Journals Note References Index Similar Titles Roitt's Essential Immunology, 11th Ed Roitt's Essential Immunology, 11th Ed ANALYTICAL METHOD VALIDATION AND INSTRUMENT PERFORMANCE VERIFICATION ANALYTICAL METHOD VALIDATION AND INSTRUMENT PERFORMANCE VERIFICATION MEDICINAL CHEMISTRY OF BIOACTIVE NATURAL PRODUCTS MEDICINAL CHEMISTRY OF BIOACTIVE NATURAL PRODUCTS INTRODUCTION TO MEDICINAL CHEMISTRY: HOW DRUGS ACT AND WHY INTRODUCTION TO MEDICINAL CHEMISTRY: HOW DRUGS ACT AND WHY