Cargando…
Stephens' Detection and Evaluation of Adverse Drug Reactions : Principles and Practice.
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 r...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken :
John Wiley & Sons,
2011.
|
| Edición: | 6th ed. |
| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Stephens' Detection and Evaluation of Adverse Drug Reactions : Principles and Practice; Contents; 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 assessment1.10 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; References; 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 companies2.7 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; 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 Trials--Collecting Safety Data and Establishing the Adverse Drug Reactions Profile4.1 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; References; 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; 5.12 Conclusions; 5.13 Appendix; References; 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.