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Adverse drug reactions / / edited by Anne Lee
| Adverse drug reactions / / edited by Anne Lee |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | London ; ; Chicago : , : Pharmaceutical Press, , 2006 |
| Descrizione fisica | 1 online resource (xxi, 474 p. ) |
| Disciplina | 615/.7042 |
| Soggetto topico | Drugs - Side effects |
| ISBN | 0-85711-113-2 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Cover -- Prelims -- Contents -- Preface -- Acknowledgements -- About the editor -- Contributors -- Chapter 1 - Introduction -- Epidemiology -- Classification and mechanisms -- Susceptibility -- Detection and diagnosis -- Healthcare professionals and adverse drug reactions -- References -- Further reading -- Chapter 2 - Side effects and patients -- Introduction -- Desire for information about side effects -- General perceptions -- Side effects and compliance -- Mandatory patient information leaflets -- Format of side-effect data for patients -- Key effects to consider when presenting side-effect data -- Patient reporting of ADRs -- The way forward -- References -- Further reading -- Chapter 3 - Pharmacogenetics and adverse drug reactions -- Introduction -- Adverse drug reactions -- Drug action -- Genetics revisited -- Genetic polymorphism and drug transporters -- Genetically determined pharmacodynamic variations -- Human leukocyte antigens and adverse drug reactions -- Utility of pharmacogenetics in the clinical setting -- References -- Further reading -- Glossary -- Chapter 4 - Adverse drug reactions in pregnancy -- Introduction -- Prescribing in pregnancy -- Drugs used to treat selected cardiovascular system disorders -- Drugs used to treat epilepsy -- Mental health disorders -- Drugs used in endocrine disorders -- Drugs used to treat infections -- Miscellaneous agents -- Summary -- References -- Further reading -- Glossary -- Chapter 5 - Drug-induced skin reactions -- Introduction -- Classification and mechanism -- Diagnosis -- Management points -- Exanthematous (erythematous) reactions -- Fixed drug eruption -- Urticaria and angio-oedema -- Acne -- Psoriasis and psoriasiform eruptions -- Purpura -- Vasculitis -- Erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis -- Blistering drug eruptions -- Photosensitivity.
Lichenoid drug eruptions -- Pigmentary disorders -- Alopecia -- Hair gain -- Nail disorders -- References -- Further reading -- Chapter 6 - Gastrointestinal disorders -- Introduction -- The mouth -- The oesophagus -- Nausea and vomiting -- Stomach and duodenum -- Small intestine -- Colon -- Constipation -- Pancreatitis -- References -- Further reading -- Chapter 7 - Hepatic disorders -- Introduction -- Classification and mechanisms -- Signs and symptoms of liver disorders -- Risk factors -- Diagnosis of drug-induced liver damage -- Types of drug-induced liver disease -- Management of patients with drug-induced hepatic disease -- Prevention of drug-induced hepatic damage -- References -- Further reading -- Chapter 8 - Renal disorders -- Introduction -- Risk factors -- Diagnosis of drug-induced renal dysfunction -- Acute renal failure -- Chronic renal failure -- Nephrogenic diabetes insipidus -- Haemolytic uraemic syndrome -- Osmotic nephrosis -- Conclusion -- References -- Further reading -- Chapter 9 - Endocrine and metabolic disorders -- Introduction -- Drugs affecting thyroid function -- Medicines that may interfere with thyroid function tests -- Drugs affecting adrenal function -- Aldosterone synthesis -- Drugs affecting gonadotrophin release and gonadal function -- Hyperprolactinaemia -- Syndrome of inappropriate secretion of antidiuretic hormone -- Hyperglycaemia and diabetes -- Hypoglycaemia -- Disorders of fat metabolism -- References -- Further reading -- Chapter 10 - Respiratory disorders -- Introduction -- Nasal congestion -- Airway obstruction -- Parenchymal lung disorders -- Pulmonary oedema -- Pulmonary thromboembolism -- References -- Further reading -- Chapter 11 - Musculoskeletal disorders -- Introduction -- Muscle disorders -- Bone -- Joints -- Connective tissue -- References -- Further reading -- Chapter 12 - Blood disorders. Introduction -- Aplastic anaemia -- Agranulocytosis -- Thrombocytopenia -- Pure red cell aplasia -- Haemolytic anaemia -- Megaloblastic anaemia -- References -- Further reading -- Chapter 13 - Mental health disorders -- Introduction -- Depression -- Psychosis -- Mania -- Behavioural toxicity -- Cognitive impairment -- Psychiatric manifestations of drug withdrawal reactions -- Use of SSRIs and venlafaxine in children and adolescents with major depressive disorder (MDD) -- Serotonin syndrome and neuroleptic malignant syndrome -- Management of drug-induced psychiatric disturbances -- References -- Further reading -- Chapter 14 - Cardiovascular effects -- Introduction -- Disorders of cardiac rhythm -- Disorders of systemic blood pressure -- Congestive heart failure -- Myocardial toxicity -- Pulmonary hypertension -- Stroke and heart attack risk -- References -- Further reading -- Chapter 15 - Neurological disorders -- Introduction -- Headache -- Effects on the neuromuscular junction and myasthenia gravis -- Seizures -- Coma and encephalopathy -- Neuropathies -- Guillain-Barré syndrome -- Drug-induced movement disorders -- Sudden sleep onset with dopaminergic drugs -- References -- Chapter 16 - Sexual dysfunction and infertility -- Introduction -- Infertility -- Sexual dysfunction -- References -- Further reading -- Index. |
| Record Nr. | UNINA-9910164945803321 |
| London ; ; Chicago : , : Pharmaceutical Press, , 2006 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
An introduction to pharmacovigilance / / Patrick Waller, Mira Harrison-Woolrych
| An introduction to pharmacovigilance / / Patrick Waller, Mira Harrison-Woolrych |
| Autore | Waller Patrick <1957 January 30-> |
| Edizione | [Second edition.] |
| Pubbl/distr/stampa | Chichester, West Sussex, UK ; ; Hoboken, NJ : , : John Wiley & Sons Incorporated, , 2017 |
| Descrizione fisica | 1 online resource (193 pages) : illustrations |
| Disciplina | 615/.7042 |
| Collana | THEi Wiley ebooks |
| Soggetto topico |
Drug monitoring
Drugs - Side effects |
| ISBN |
1-119-28978-5
1-119-28975-0 1-119-28977-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | What is pharmacovigilance and how has it developed? -- Basic concepts -- Types and sources of data -- The process of pharmacovigilance -- Regulatory aspects of pharmacovigilance -- International collaboration -- Clinical aspects of adverse drug reactions -- Ethical and societal considerations -- Future directions -- Learning more about pharmacovigilance. |
| Record Nr. | UNINA-9910165027303321 |
Waller Patrick <1957 January 30->
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| Chichester, West Sussex, UK ; ; Hoboken, NJ : , : John Wiley & Sons Incorporated, , 2017 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmacoepidemiology [[electronic resource] /] / edited by Brian L. Strom, Stephen E. Kimmel, Sean Hennessy
| Pharmacoepidemiology [[electronic resource] /] / edited by Brian L. Strom, Stephen E. Kimmel, Sean Hennessy |
| Edizione | [5th ed.] |
| Pubbl/distr/stampa | Chichester, West Sussex, UK, : Wiley-Blackwell, 2012 |
| Descrizione fisica | 1 online resource (977 p.) |
| Disciplina | 615/.7042 |
| Altri autori (Persone) |
StromBrian L
KimmelStephen E HennessySean |
| Soggetto topico |
Pharmacoepidemiology
Pharmacology |
| ISBN |
1-280-59892-1
9786613628756 1-119-95994-2 1-119-95991-8 1-119-95992-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Pharmacoepidemiology, FIFTH EDITION; Contents; List of Contributors; Preface; Acknowledgements; PART I: Introduction; CHAPTER 1: What is Pharmacoepidemiology?; CHAPTER 2: Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies; CHAPTER 3: Basic Principles of Clinical Epidemiology Relevant to Pharmacoepidemiologic Studies; CHAPTER 4: Sample Size Considerations for Pharmacoepidemiologic Studies; CHAPTER 5: When Should One Perform Pharmacoepidemiologic Studies?; PART I I: The Role of Pharmacoepidemiology in Different Sectors
CHAPTER 6: The Role of Pharmacoepidemiology in the Health-Care System and AcademiaCHAPTER 7: The Role of Pharmacoepidemiology in Industry; CHAPTER 8: The Role of Pharmacoepidemiology in Regulatory Agencies; CHAPTER 9: Pharmacoepidemiology and the Law; PART I I I: Sources of Data for Pharmacoepidemiologic Studies; Section A: Spontaneous Reporting; CHAPTER 10: Postmarketing Spontaneous Pharmacovigilance Reporting Systems; Section B: Automated Data Systems; CHAPTER 11: Overview of Automated Databases in Pharmacoepidemiology; CHAPTER 12: Health Maintenance Organizations/Health Plans CHAPTER 13: Commercial Insurance DatabasesCHAPTER 14: US Government Claims Databases; CHAPTER 15: Medical Record Databases; CHAPTER 16: In-hospital Databases; CHAPTER 17: Canadian Provincial Databases; CHAPTER 18: Pharmacy-based Medical Record Linkage Systems; Section C: Ad Hoc Studies-Ongoing Systems for Pharmacoepidemiologic Studies; CHAPTER 19: Case-Control Surveillance; CHAPTER 20: Prescription-Event Monitoring; CHAPTER 21: Registries; Section D: Ad Hoc Studies-De Novo Studies; CHAPTER 22: Field Studies; Section E: Choosing Among the Available Alternatives CHAPTER 23: How Should One Perform Pharmacoepidemiologic Studies? Choosing Among the Available AlternativesPART IV: Selected Special Applications of Pharmacoepidemiology; CHAPTER 24: Studies of Drug Utilization; CHAPTER 25: Evaluating and Improving Physician Prescribing; CHAPTER 26: Pharmacoepidemiologic Studies of Vaccine Safety; CHAPTER 27: Epidemiologic Studies of Medical Devices: Methodologic Considerations for Implantable Devices; CHAPTER 28: Studies of Drug-Induced Birth Defects; CHAPTER 29: Risk Management CHAPTER 30: FDA's Sentinel Initiative: Active Surveillance to Identify Safety SignalsCHAPTER 31: Pharmacoepidemiology and Pharmaceutical Reimbursement Policy; CHAPTER 32: Comparative Effectiveness Research; PART V: Selected Special Methodologic Issues in Pharmacoepidemiology; CHAPTER 33: Assessing Causality of Case Reports of Suspected Adverse Events; CHAPTER 34: Molecular Pharmacoepidemiology; CHAPTER 35: Bioethical Issues in Pharmacoepidemiologic Research; CHAPTER 36: The Use of Randomized Controlled Trials for Pharmacoepidemiologic Studies CHAPTER 37: The Use of Pharmacoepidemiology to Study Beneficial Drug Effects |
| Record Nr. | UNINA-9910789877703321 |
| Chichester, West Sussex, UK, : Wiley-Blackwell, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Stephens' detection and evaluation of adverse drug reactions [[electronic resource] ] : principles and practice / / edited by John Talbot, Jeffrey K. Aronson
| Stephens' detection and evaluation of adverse drug reactions [[electronic resource] ] : principles and practice / / edited by John Talbot, Jeffrey K. Aronson |
| Edizione | [6th ed.] |
| Pubbl/distr/stampa | Chichester, U.K., : John Wiley & Sons, 2012 |
| Descrizione fisica | 1 online resource (752 p.) |
| Disciplina | 615/.7042 |
| Altri autori (Persone) |
TalbotJ. C. C
AronsonJ. K StephensM. D. B. <1930-> |
| Soggetto topico |
Drugs - Side effects
Drugs - Toxicology |
| ISBN |
1-283-39742-0
9786613397423 1-119-95210-7 0-470-97505-9 0-470-97504-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 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. |
| Record Nr. | UNINA-9910141191203321 |
| Chichester, U.K., : John Wiley & Sons, 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Stephens' detection and evaluation of adverse drug reactions : principles and practice / / edited by John Talbot, Jeffrey K. Aronson
| Stephens' detection and evaluation of adverse drug reactions : principles and practice / / edited by John Talbot, Jeffrey K. Aronson |
| Edizione | [6th ed.] |
| Pubbl/distr/stampa | Chichester, U.K., : John Wiley & Sons, 2012 |
| Descrizione fisica | 1 online resource (752 p.) |
| Disciplina | 615/.7042 |
| Altri autori (Persone) |
TalbotJ. C. C
AronsonJ. K StephensM. D. B. <1930-> |
| Soggetto topico |
Drugs - Side effects
Drugs - Toxicology |
| ISBN |
9786613397423
9781283397421 1283397420 9781119952107 1119952107 9780470975053 0470975059 9780470975046 0470975040 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 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. |
| Altri titoli varianti | Detection and evaluation of adverse drug reactions |
| Record Nr. | UNINA-9910815194603321 |
| Chichester, U.K., : John Wiley & Sons, 2012 | ||
| 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-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 |
9786610269327
9781280269325 1280269324 9780470092651 0470092653 9780470014196 0470014199 |
| 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-9911019287403321 |
| Chichester ; ; Hoboken, NJ, : Wiley, c2004 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||