Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice, Sixth Edition

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 Content: Chapter 1 Adverse Drug Reactions: History, Terminology, Classification, Causality, Frequency, Preventability (pages 1–119): Jeffrey K. Aronson Chapter 2 Pharmacogenetics of Adverse Drug Reactions (pages 121–156): Sudeep P. Pushpakom and Munir Pirmohamed Chapter 3 Toxicology and Adverse Drug Reactions (pages 157–214): D. J. Snodin and A. Suitters Chapter 4 Clinical Trials—Collecting Safety Data and Establishing the Adverse Drug Reactions Profile (pages 215–289): John Talbot, Marianne Keisu and Lars Stahle Chapter 5 Clinical Laboratory Safety Data (pages 291–348): Alan Craig Chapter 6 Statistics: Analysis and Presentation of Safety Data (pages 349–388): Stephen J. W. Evans and Dorothea Nitsch Chapter 7 Proactive Pharmacovigilance and Risk Management (pages 389–409): June Raine, Lesley Wise, John Talbot and Jeffrey K. Aronson Chapter 8 Regulatory Aspects of Pharmacovigilance (pages 411–509): Kristina Leila Strutt and Barry David Charles Arnold Chapter 9 Legal Aspects of Pharmacovigilance in the European Union (pages 511–543): Christine H. Bendall Chapter 10 Dictionaries and Coding in Pharmacovigilance (pages 545–572): E. G. Brown and J. E. Harrison Chapter 11 Adverse Drug Reactions: Societal Considerations (pages 573–584): Nicky Britten Chapter 12 Safety of Biotherapeutics (pages 585–601): Andrew Erdman, James Nickas and Benton Brown Chapter 13 Vaccine Safety Surveillance (pages 603–624): E. Miller and J. Stowe Chapter 14 Assessing the Safety of Drugs Used in Oncology (pages 625–643): Anne Kehely Chapter 15 Adverse Drug Reactions and Pharmacovigilance of Herbal Medicines (pages 645–683): Joanne Barnes 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__Content: Chapter 1 Adverse Drug Reactions: History, Terminology, Classification, Causality, Frequency, Preventability (pages 1–119): Jeffrey K. AronsonChapter 2 Pharmacogenetics of Adverse Drug Reactions (pages 121–156): Sudeep P. Pushpakom and Munir PirmohamedChapter 3 Toxicology and Adverse Drug Reactions (pages 157–214): D. J. Snodin and A. SuittersChapter 4 Clinical Trials—Collecting Safety Data and Establishing the Adverse Drug Reactions Profile (pages 215–289): John Talbot, Marianne Keisu and Lars StahleChapter 5 Clinical Laboratory Safety Data (pages 291–348): Alan CraigChapter 6 Statistics: Analysis and Presentation of Safety Data (pages 349–388): Stephen J. W. Evans and Dorothea NitschChapter 7 Proactive Pharmacovigilance and Risk Management (pages 389–409): June Raine, Lesley Wise, John Talbot and Jeffrey K. AronsonChapter 8 Regulatory Aspects of Pharmacovigilance (pages 411–509): Kristina Leila Strutt and Barry David Charles ArnoldChapter 9 Legal Aspects of Pharmacovigilance in the European Union (pages 511–543): Christine H. BendallChapter 10 Dictionaries and Coding in Pharmacovigilance (pages 545–572): E. G. Brown and J. E. HarrisonChapter 11 Adverse Drug Reactions: Societal Considerations (pages 573–584): Nicky BrittenChapter 12 Safety of Biotherapeutics (pages 585–601): Andrew Erdman, James Nickas and Benton BrownChapter 13 Vaccine Safety Surveillance (pages 603–624): E. Miller and J. StoweChapter 14 Assessing the Safety of Drugs Used in Oncology (pages 625–643): Anne KehelyChapter 15 Adverse Drug Reactions and Pharmacovigilance of Herbal Medicines (pages 645–683): Joanne Barnes Adverse drug reactions : history, terminology, classification, causality, frequency, preventability / Jeffrey K. Aronson Pharmacogenetics of adverse drug reactions / Sudeep P. Pushpakom & Munir Pirmohamed Toxicology and adverse drug reactions / D.J. Snodin & A. Suitters Clinical trials' collecting safety data and establishing the adverse drug reactions profile / John Talbot, Marianne Keisu & Lars Stohle Clinical laboratory safety data / Alan Craig Statistics : analysis and presentation of safety data / Stephen J.W. Evans & Dorothea Nitsch Proactive pharmacovigilance and risk management / June Raine ... [et al.] Regulatory aspects of pharmacovigilance / K.L. Strutt & B.D.C. Arnold Legal aspects of pharmacovigilance in the European Union / Christine H. Bendall Dictionaries and coding in pharmacovigilance / E.G. Brown & J.E. Harrison Adverse drug reactions : societal considerations / Nicky Britten Safety of biotherapeutics / Andrew Erdman, James Nickas & Benton Brown Vaccine safety surveillance / E. Miller & J. Stowe The adverse effects of drugs used in oncology / Anne Kehely Adverse drug reactions and pharmacovigilance of herbal medicines / Joanne Barnes. 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. The classic text covers the issues and problems involved in the detection of adverse drug reactions (ADRs) throughout the life cycle of a medicine from animal studies through to clinical trials, its introduction to the market, followed by wide clinical use, and eventual decline in use or withdrawal. The sixth edition is completely revised and updated including five new chapters on pharm 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.