07215nam 22016933u 450 991013990320332120210113165307.01-282-25005-1978661225005792-4-068371-2(CKB)1000000000804064(EBL)456324(OCoLC)312414630(SSID)ssj0000306663(PQKBManifestationID)12099017(PQKBTitleCode)TC0000306663(PQKBWorkID)10299140(PQKB)11630015(MiAaPQ)EBC456324(Au-PeEL)EBL456324(CaONFJC)MIL225005(OCoLC)935270628(EXLCZ)99100000000080406420130418d2008|||| u|| |engur|n|---|||||txtccrA Practical Handbook on the Pharmacovigilance of Antimalarial Medicines[electronic resource]Geneva World Health Organization20081 online resource (175 p.)Description based upon print version of record.92-4-154749-9 COVER; TITLE; COPYRIGHT; TABLE OF CONTENTS; FOREWORD; PART 1: GUIDANCE DOCUMENT ON CHARACTERIZING AND COMMUNICATING UNCERTAINTY IN EXPOSURE ASSESSMENT; ACKNOWLEDGEMENTS; MEMBERS OF THE WHO/IPCS WORKING GROUP ON UNCERTAINTY IN EXPOSURE ASSESSMENT; LIST OF ACRONYMS AND ABBREVIATIONS; EXECUTIVE SUMMARY; 1. INTRODUCTION; 2. CONTEXT, CONCEPTS AND DEFINITIONS; 3. SOURCES OF UNCERTAINTY; 4. TIERED APPROACH TO UNCERTAINTY ANALYSIS; 5. UNCERTAINTY CHARACTERIZATION METHODS, INTERPRETATION AND USE; 6. COMMUNICATION; 7. CONCLUSIONS; 8. REFERENCES; GLOSSARY OF TERMSANNEX 1: CASE-STUDY-QUALITATIVE UNCERTAINTY ANALYSISAppendix 1: Background for case-study; ANNEX 2: CASE-STUDY-QUANTITATIVE UNCERTAINTY ANALYSIS; PART 2: HALLMARKS OF DATA QUALITY IN CHEMICAL EXPOSURE ASSESSMENT; PREPARATION OF THE DOCUMENT; 1. INTRODUCTION; 2. WHAT DO WE MEAN BY "DATA" IN EXPOSURE ASSESSMENT?; 3. TOWARDS A BROADER DEFINITION OF QUALITY IN EXPOSURE ASSESSMENT: HALLMARKS OF DATA QUALITY; 4. FROM EXPOSURE DATA QUALITY TO THE QUALITY OF EXPOSURE ASSESSMENTS; 5. CONCLUSIONS; 6. REFERENCES; Back Cover""The Handbook"" is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antimalarials. It is intended to be a source of practical advice for pharmacovigilance centres. It provides information on spontaneous reporting of adverse drug reactions as a complement to other WHO publications. In addition, it provides details on how to conduct cohort event monitoring, which is a method of active safety surveillance collecting information on all adverse events occurring after treatment. It also details how to perform causality assessment and signal identification, apPractical Handbook on the Pharmacovigilance of Antimalarial MedicinesAdverse Drug Reaction Reporting SystemsAntimalarials -- standardsAntimalarialsDrug MonitoringDrug Utilization Review -- methodsPharmacoepidemiology -- methodsProduct Surveillance, PostmarketingDrug monitoringSide effectsAntimalarialsDrug MonitoringDrug Utilization ReviewProduct Surveillance, PostmarketingAdverse Drug Reaction Reporting SystemsPharmacoepidemiologyAntimalarialsMethodsUtilization ReviewAntiprotozoal AgentsInvestigative TechniquesDrug UtilizationPharmacologyEpidemiologyEvaluation Studies as TopicMonitoring, PhysiologicQuality of Health CareQuality Assurance, Health CarePublic HealthHealth OccupationsBiological Science DisciplinesAnalytical, Diagnostic and Therapeutic Techniques and EquipmentDiagnostic Techniques and ProceduresPharmacy AdministrationAntiparasitic AgentsDisciplines and OccupationsMedicineHealth Services AdministrationNatural Science DisciplinesHealth Care Quality, Access, and EvaluationOrganization and AdministrationDiagnosisAnti-Infective AgentsTherapeutic UsesHealth CarePharmacologic ActionsChemical Actions and UsesChemicals and DrugsPharmacy, Therapeutics, & PharmacologyHILCCHealth & Biological SciencesHILCCElectronic books.Adverse Drug Reaction Reporting Systems.Antimalarials -- standards.Antimalarials.Drug Monitoring.Drug Utilization Review -- methods.Pharmacoepidemiology -- methods.Product Surveillance, Postmarketing.Drug monitoringSide effectsAntimalarialsDrug MonitoringDrug Utilization ReviewProduct Surveillance, PostmarketingAdverse Drug Reaction Reporting SystemsPharmacoepidemiologyAntimalarialsMethodsUtilization ReviewAntiprotozoal AgentsInvestigative TechniquesDrug UtilizationPharmacologyEpidemiologyEvaluation Studies as TopicMonitoring, PhysiologicQuality of Health CareQuality Assurance, Health CarePublic HealthHealth OccupationsBiological Science DisciplinesAnalytical, Diagnostic and Therapeutic Techniques and EquipmentDiagnostic Techniques and ProceduresPharmacy AdministrationAntiparasitic AgentsDisciplines and OccupationsMedicineHealth Services AdministrationNatural Science DisciplinesHealth Care Quality, Access, and EvaluationOrganization and AdministrationDiagnosisAnti-Infective AgentsTherapeutic UsesHealth CarePharmacologic ActionsChemical Actions and UsesChemicals and DrugsPharmacy, Therapeutics, & PharmacologyHealth & Biological Sciences600World Health OrganizationAU-PeELAU-PeELAU-PeELBOOK9910139903203321A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines2876288UNINA