


Stephens' Detection and Evaluation of Adverse Drug Reactions. Principles and Practice
Talbot, J. — Aronson, J.
6ª Edición Diciembre 2011
Inglés
Tapa dura
752 pags
2000 gr
x x cm
ISBN 9780470986349
Editorial WILEY
Recíbelo en un plazo De 7 a 10 días
Description
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 pharmacogenomics, ADRs with herbal medicines, safety of medical devices, safety issues with oncology drugs, and economic aspects of ADRs. All tables and web information needed in order to practice are included to make this sixth edition a complete primer for the new practitioner and a reference for the more experienced.
Table of Contents
- Foreword
- Preface to the Sixth Edition
- List of Contributors
- Acknowledgements
- Adverse Drug Reactions: History, Terminology, Classification, Causality, Frequency, Preventability
Jeffrey K. Aronson - Introduction
- Defining pharmacovigilance
- The modern history of pharmacovigilance
- Terminology and definitions in pharmacovigilance
- Medication errors
- Pharmacological classification of adverse drug reactions
- Drug interactions
- Reporting suspected adverse drug reactions
- Causality assessment
- Frequencies of adverse drug reactions
- Risk perception and adverse drug reactions
- Class effects of drugs
- Unlicensed indications, off-label uses, and orphan drugs
- Preventing adverse drug reactions
- Publishing accounts of adverse drug reactions
- References
- Pharmacogenetics of Adverse Drug Reactions
Sudeep P. Pushpakom and Munir Pirmohamed - Introduction
- Historical review
- Sources of genetic variability
- Role of pharmacogenetic factors in drug pharmacokinetics
- Role of pharmacogenetic factors in drug pharmacodynamics
- The role of pharmacogenetics in pharmaceutical companies
- The impact of pharmacogenetics on regulatory agencies
- The impact of pharmacogenetics on clinical practice
- Conclusions
- References
- Toxicology and Adverse Drug Reactions
D. J. Snodin and A. Suitters - Introduction
- Toxicity testing
- Drug discovery and development
- Data interpretation and risk assessment
- Adverse drug reactions detected after marketing authorization
- Examples of toxicological investigation of ADRs
- Conclusions
- Acknowledgements
- References
- Clinical Trials—Collecting Safety Data and Establishing the Adverse Drug Reactions Profile
John Talbot, Marianne Keisu, and Lars St°ahle - Introduction
- Adverse events
- Clinical studies and safety
- The emerging safety profile
- Presentation of safety data
- Conclusions
- References
- Clinical Laboratory Safety Data
Alan Craig - Introduction
- Factors that influence the interpretation of clinical laboratory data
- Sample collection procedure
- Analytical variation
- Reference ranges
- Intra-individual biological variation
- Detecting adverse events during drug development
- Test selection
- Exclusion criteria and “panic levels”
- Harmonization of data from different laboratories
- Data analysis and presentation
- Conclusions
- Appendix
- References
- Statistics: Analysis and Presentation of Safety Data
Stephen J. W. Evans and Dorothea Nitsch - Introduction and background
- Problems with efficacy trials for detecting adverse drug reactions
- Analysis and presentation of data from trials
- Statistical measures of the occurrence of adverse events
- Combining data from several trials—meta-analysis
- Use of statistical methods for signal detection from spontaneous reports
- Analysis and presentation of data from observational studies
- Summary and conclusions
- Acknowledgements
- References
- Proactive Pharmacovigilance and Risk Management
June Raine, Lesley Wise, John Talbot, and Jeffrey K. Aronson - Introduction
- Risk management—definition and general principles
- Defining the knowledge base—the safety specification
- Extending the knowledge of safety and characterizing risk—the pharmacovigilance plan
- Minimizing risks
- Special challenges for risk management
- Experience with risk evaluation and mitigation strategies (REMS) in the USA
- A possible method for risk management when a new adverse reaction is discovered after marketing
- Future challenges for risk management
- Conclusions
- References
- Regulatory Aspects of Pharmacovigilance
Kristina Leila Strutt and Barry David Charles Arnold - Introduction
- The standardization and harmonization of safety data collection and reporting: CIOMS and ICH
- The European Union
- The UK
- France
- Germany
- USA
- Japan
- Acknowledgements
- References
- Useful web sites
- Legal Aspects of Pharmacovigilance in the European Union
Christine H. Bendall - Introduction
- Application of EU legislation in Member States
- Interpretation of EU law
- Relationship between law and guidelines
- Issues in interpreting EU pharmacovigilance legislation
- Legal responsibility for pharmacovigilance activities
- Failures to meet pharmacovigilance requirements
- Enforcement and sanctions
- European powers and procedures in the event of a product safety issue
- Civil liability
- Personal data privacy
- Safety in research products
- References
- Dictionaries and Coding in Pharmacovigilance
E. G. Brown and J. E. Harrison - Introduction
- Scope of this chapter
- What is a dictionary?
- Drug dictionaries
- Disease classifications
- Medical Dictionary for Regulatory Activities, MedDRA R
- Common Terminology Criteria for Adverse Events (CTCAE)
- Definition of adverse reaction terms
- Dictionaries used in electronic health records
- Use of dictionaries in standard product information
- Conclusions
- Acknowledgements
- References
- Adverse Drug Reactions: Societal Considerations
Nicky Britten - Introduction
- Adverse drug reactions at the population level
- The social production of ADRs
- Trust
- Information about ADRs
- Conclusions
- References
- Safety of Biotherapeutics
Andrew Erdman, James Nickas, and Benton Brown - Introduction
- Properties of proteins
- Classification of biotherapeutics
- Monitoring for adverse events due to biotherapeutics
- Conclusions
- References
- Vaccine Safety Surveillance
E. Miller and J. Stowe - Introduction
- What is special about vaccine safety compared with other drugs?
- Pathogenesis of vaccine reactions
- Criteria for establishing causality after vaccine-related adverse events
- Pre-licensing evaluation of vaccine safety
- Objectives of an ideal post-licensing vaccine safety surveillance system
- Conclusions
- References
- Assessing the Safety of Drugs Used in Oncology
Anne Kehely - Introduction
- Factors to consider when assessing the safety of drugs used in oncology
- Sources of adverse effect data
- Nature of the data
- Assessment of adverse effects data in oncology
- Conclusions
- References
- 15 Adverse Drug Reactions and Pharmacovigilance of Herbal Medicines, Joanne Barnes
- Introduction
- Herbal medicines: definitions and descriptions
- Characteristics of herbal medicines
- Regulation of herbal medicines and pharmacovigilance requirements
- Access to and use of herbal medicines
- Adverse reactions associated with herbal medicines
- Methods for pharmacovigilance of herbal medicines
- Responding to safety concerns associated with herbal medicines
- The future for pharmacovigilance of herbal medicines
- Conclusions
- References
- Appendix 1 Web Sites Relevant to Pharmacovigilance—An Analysis of Contents, Charlotte I. S. Barker, John Talbot, and Jeffrey K. Aronson
- Introduction
- Ten national pharmacovigilance web sites
- Twelve institutional web sites
- Acknowledgements
- References
- Appendix 2 Guidelines and a Checklist for Reporting Suspected Adverse Drug Reactions Anecdotally in Journals, Jeffrey K. Aronson
- Introduction
- Notes on the checklist
- Conclusions
- Note
- References
- Index
Fax91 448 21 88
DirC / Raimundo Lulio, 1, 28010 Madrid, España.
Mailpedidosweb@axon.esPrivacidadCondiciones de ventaQuiénes SomosAvisoContacto© 2021 Axón Librería S.L.
v1.51.0