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Stephens' detection of new adverse drug reactions / / edited by John Talbot, Patrick Waller
| Stephens' detection of new adverse drug reactions / / edited by John Talbot, Patrick Waller |
| Edizione | [5th ed.] |
| Pubbl/distr/stampa | Chichester ; ; Hoboken, NJ, : Wiley, c2004 |
| Descrizione fisica | 1 online resource (763 p.) |
| Disciplina |
615.7042
615/.7042 |
| Altri autori (Persone) |
StephensM. D. B. <1930->
TalbotJ. C. C WallerPatrick |
| Soggetto topico |
Drugs - Side effects
Drugs - Toxicology |
| ISBN |
1-280-26932-4
9786610269327 0-470-09265-3 0-470-01419-9 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Stephens' Detection of New Adverse Drug Reactions Fifth Edition; Contents; Foreword; Preface; List of Contributors; 1 Introduction; Mercury; Introduction to pharmacovigilance; The history of pharmacovigilance; Under-reporting of adverse drug reactions; Incidence of adverse drug reactions; The financial cost of adverse drug reactions; Preventability of adverse drug reactions; Risk-benefit ratio; The changing risks with new drugs; Expression of risk; The risks we are prepared to take; Definitions; Classification of adverse drug reactions; Adverse reaction profile
Adverse events in a patient's lifeSymptoms in healthy persons; Adverse reactions to placebo; Infectiousness of adverse drug reactions; Herbal medicines; Some final food for thought; References; Further reading; 2 Adverse Drug Reactions and Interactions: Mechanisms, Risk Factors, Detection, Management and Prevention; Introduction; Classification of adverse drug reactions; Risk factors for type A adverse reactions; Risk factors for type B adverse reactions; Detection of adverse drug reactions; Management of adverse drug reactions; Prevention of adverse drug reactions; Drug interactions ConclusionsReferences; 3 Toxicology and Adverse Drug Reactions; Introduction; Toxicity testing; Drug development; Data interpretation and risk assessment; Adverse drug reactions detected after authorization; Examples of toxicological investigation of adverse drug reactions; Conclusions; Acknowledgements; References; 4 Clinical Trials: Collection of Safety Data and Establishing the Adverse Drug Reaction Profile; Introduction; Adverse events; Final analysis of data; Inadequate reporting of safety data from clinical trials; Conclusions; Future aspirations; Acknowledgements; References 5 Clinical Laboratory Safety Data in Drug StudiesIntroduction; Factors that influence interpretation of clinical laboratory data; Sample collection procedure; Analytical variation; Reference ranges; Intra-individual biological variation; Safety testing in drug development; Test selection; Exclusion criteria and 'panic levels'; Harmonization of data from different laboratories; Data analysis and presentation; Conclusion; References; 6 Statistics: Analysis and Presentation of Safety Data; Introduction and background; Analysis and presentation of data from trials Measures that take time into accountStatistical tests utilizing time since start of treatment; Combining data from several trials: meta-analysis; Analysis and presentation of data from observational studies; Use of statistical methods for signal detection with spontaneous reports; Summary and conclusions; Acknowledgements; References; 7 Causality and Correlation in Pharmacovigilance; Introduction and historical background; The notions of necessary and sufficient causes; Factors to be considered in causality assessment; Methods for causality assessment; When to assess causality Assessing causality from multiple information sources: the Bradford-Hill criteria |
| Record Nr. | UNINA-9910145754503321 |
| Chichester ; ; Hoboken, NJ, : Wiley, c2004 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Stephens' detection of new adverse drug reactions / / edited by John Talbot, Patrick Waller
| Stephens' detection of new adverse drug reactions / / edited by John Talbot, Patrick Waller |
| Edizione | [5th ed.] |
| Pubbl/distr/stampa | Chichester ; ; Hoboken, NJ, : Wiley, c2004 |
| Descrizione fisica | 1 online resource (763 p.) |
| Disciplina |
615.7042
615/.7042 |
| Altri autori (Persone) |
StephensM. D. B. <1930->
TalbotJ. C. C WallerPatrick |
| Soggetto topico |
Drugs - Side effects
Drugs - Toxicology |
| ISBN |
1-280-26932-4
9786610269327 0-470-09265-3 0-470-01419-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Stephens' Detection of New Adverse Drug Reactions Fifth Edition; Contents; Foreword; Preface; List of Contributors; 1 Introduction; Mercury; Introduction to pharmacovigilance; The history of pharmacovigilance; Under-reporting of adverse drug reactions; Incidence of adverse drug reactions; The financial cost of adverse drug reactions; Preventability of adverse drug reactions; Risk-benefit ratio; The changing risks with new drugs; Expression of risk; The risks we are prepared to take; Definitions; Classification of adverse drug reactions; Adverse reaction profile
Adverse events in a patient's lifeSymptoms in healthy persons; Adverse reactions to placebo; Infectiousness of adverse drug reactions; Herbal medicines; Some final food for thought; References; Further reading; 2 Adverse Drug Reactions and Interactions: Mechanisms, Risk Factors, Detection, Management and Prevention; Introduction; Classification of adverse drug reactions; Risk factors for type A adverse reactions; Risk factors for type B adverse reactions; Detection of adverse drug reactions; Management of adverse drug reactions; Prevention of adverse drug reactions; Drug interactions ConclusionsReferences; 3 Toxicology and Adverse Drug Reactions; Introduction; Toxicity testing; Drug development; Data interpretation and risk assessment; Adverse drug reactions detected after authorization; Examples of toxicological investigation of adverse drug reactions; Conclusions; Acknowledgements; References; 4 Clinical Trials: Collection of Safety Data and Establishing the Adverse Drug Reaction Profile; Introduction; Adverse events; Final analysis of data; Inadequate reporting of safety data from clinical trials; Conclusions; Future aspirations; Acknowledgements; References 5 Clinical Laboratory Safety Data in Drug StudiesIntroduction; Factors that influence interpretation of clinical laboratory data; Sample collection procedure; Analytical variation; Reference ranges; Intra-individual biological variation; Safety testing in drug development; Test selection; Exclusion criteria and 'panic levels'; Harmonization of data from different laboratories; Data analysis and presentation; Conclusion; References; 6 Statistics: Analysis and Presentation of Safety Data; Introduction and background; Analysis and presentation of data from trials Measures that take time into accountStatistical tests utilizing time since start of treatment; Combining data from several trials: meta-analysis; Analysis and presentation of data from observational studies; Use of statistical methods for signal detection with spontaneous reports; Summary and conclusions; Acknowledgements; References; 7 Causality and Correlation in Pharmacovigilance; Introduction and historical background; The notions of necessary and sufficient causes; Factors to be considered in causality assessment; Methods for causality assessment; When to assess causality Assessing causality from multiple information sources: the Bradford-Hill criteria |
| Record Nr. | UNINA-9910830124003321 |
| Chichester ; ; Hoboken, NJ, : Wiley, c2004 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Stephens' detection of new adverse drug reactions / / edited by John Talbot, Patrick Waller
| Stephens' detection of new adverse drug reactions / / edited by John Talbot, Patrick Waller |
| Edizione | [5th ed.] |
| Pubbl/distr/stampa | Chichester ; ; Hoboken, NJ, : Wiley, c2004 |
| Descrizione fisica | 1 online resource (763 p.) |
| Disciplina | 615/.7042 |
| Altri autori (Persone) |
StephensM. D. B. <1930->
TalbotJ. C. C WallerPatrick |
| Soggetto topico |
Drugs - Side effects
Drugs - Toxicology |
| ISBN |
1-280-26932-4
9786610269327 0-470-09265-3 0-470-01419-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Stephens' Detection of New Adverse Drug Reactions Fifth Edition; Contents; Foreword; Preface; List of Contributors; 1 Introduction; Mercury; Introduction to pharmacovigilance; The history of pharmacovigilance; Under-reporting of adverse drug reactions; Incidence of adverse drug reactions; The financial cost of adverse drug reactions; Preventability of adverse drug reactions; Risk-benefit ratio; The changing risks with new drugs; Expression of risk; The risks we are prepared to take; Definitions; Classification of adverse drug reactions; Adverse reaction profile
Adverse events in a patient's lifeSymptoms in healthy persons; Adverse reactions to placebo; Infectiousness of adverse drug reactions; Herbal medicines; Some final food for thought; References; Further reading; 2 Adverse Drug Reactions and Interactions: Mechanisms, Risk Factors, Detection, Management and Prevention; Introduction; Classification of adverse drug reactions; Risk factors for type A adverse reactions; Risk factors for type B adverse reactions; Detection of adverse drug reactions; Management of adverse drug reactions; Prevention of adverse drug reactions; Drug interactions ConclusionsReferences; 3 Toxicology and Adverse Drug Reactions; Introduction; Toxicity testing; Drug development; Data interpretation and risk assessment; Adverse drug reactions detected after authorization; Examples of toxicological investigation of adverse drug reactions; Conclusions; Acknowledgements; References; 4 Clinical Trials: Collection of Safety Data and Establishing the Adverse Drug Reaction Profile; Introduction; Adverse events; Final analysis of data; Inadequate reporting of safety data from clinical trials; Conclusions; Future aspirations; Acknowledgements; References 5 Clinical Laboratory Safety Data in Drug StudiesIntroduction; Factors that influence interpretation of clinical laboratory data; Sample collection procedure; Analytical variation; Reference ranges; Intra-individual biological variation; Safety testing in drug development; Test selection; Exclusion criteria and 'panic levels'; Harmonization of data from different laboratories; Data analysis and presentation; Conclusion; References; 6 Statistics: Analysis and Presentation of Safety Data; Introduction and background; Analysis and presentation of data from trials Measures that take time into accountStatistical tests utilizing time since start of treatment; Combining data from several trials: meta-analysis; Analysis and presentation of data from observational studies; Use of statistical methods for signal detection with spontaneous reports; Summary and conclusions; Acknowledgements; References; 7 Causality and Correlation in Pharmacovigilance; Introduction and historical background; The notions of necessary and sufficient causes; Factors to be considered in causality assessment; Methods for causality assessment; When to assess causality Assessing causality from multiple information sources: the Bradford-Hill criteria |
| Altri titoli varianti | Detection of new adverse drug reactions |
| Record Nr. | UNINA-9910877112503321 |
| Chichester ; ; Hoboken, NJ, : Wiley, c2004 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||