LEADER 07213nam 22016933u 450 001 996320248803316 005 20210113165307.0 010 $a1-282-25005-1 010 $a9786612250057 010 $a92-4-068371-2 035 $a(CKB)1000000000804064 035 $a(EBL)456324 035 $a(OCoLC)312414630 035 $a(SSID)ssj0000306663 035 $a(PQKBManifestationID)12099017 035 $a(PQKBTitleCode)TC0000306663 035 $a(PQKBWorkID)10299140 035 $a(PQKB)11630015 035 $a(MiAaPQ)EBC456324 035 $a(Au-PeEL)EBL456324 035 $a(CaONFJC)MIL225005 035 $a(OCoLC)935270628 035 $a(EXLCZ)991000000000804064 100 $a20130418d2008|||| u|| | 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 02$aA Practical Handbook on the Pharmacovigilance of Antimalarial Medicines$b[electronic resource] 210 $aGeneva $cWorld Health Organization$d2008 215 $a1 online resource (175 p.) 300 $aDescription based upon print version of record. 311 $a92-4-154749-9 327 $aCOVER; 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 TERMS 327 $aANNEX 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 330 $a""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, ap 517 $aPractical Handbook on the Pharmacovigilance of Antimalarial Medicines 606 $aAdverse Drug Reaction Reporting Systems 606 $aAntimalarials -- standards 606 $aAntimalarials 606 $aDrug Monitoring 606 $aDrug Utilization Review -- methods 606 $aPharmacoepidemiology -- methods 606 $aProduct Surveillance, Postmarketing 606 $aDrug monitoring$xSide effects 606 $aAntimalarials 606 $aDrug Monitoring 606 $aDrug Utilization Review 606 $aProduct Surveillance, Postmarketing 606 $aAdverse Drug Reaction Reporting Systems 606 $aPharmacoepidemiology 606 $aAntimalarials 606 $aMethods 606 $aUtilization Review 606 $aAntiprotozoal Agents 606 $aInvestigative Techniques 606 $aDrug Utilization 606 $aPharmacology 606 $aEpidemiology 606 $aEvaluation Studies as Topic 606 $aMonitoring, Physiologic 606 $aQuality of Health Care 606 $aQuality Assurance, Health Care 606 $aPublic Health 606 $aHealth Occupations 606 $aBiological Science Disciplines 606 $aAnalytical, Diagnostic and Therapeutic Techniques and Equipment 606 $aDiagnostic Techniques and Procedures 606 $aPharmacy Administration 606 $aAntiparasitic Agents 606 $aDisciplines and Occupations 606 $aMedicine 606 $aHealth Services Administration 606 $aNatural Science Disciplines 606 $aHealth Care Quality, Access, and Evaluation 606 $aOrganization and Administration 606 $aDiagnosis 606 $aAnti-Infective Agents 606 $aTherapeutic Uses 606 $aHealth Care 606 $aPharmacologic Actions 606 $aChemical Actions and Uses 606 $aChemicals and Drugs 606 $aPharmacy, Therapeutics, & Pharmacology$2HILCC 606 $aHealth & Biological Sciences$2HILCC 608 $aElectronic books. 615 4$aAdverse Drug Reaction Reporting Systems. 615 4$aAntimalarials -- standards. 615 4$aAntimalarials. 615 4$aDrug Monitoring. 615 4$aDrug Utilization Review -- methods. 615 4$aPharmacoepidemiology -- methods. 615 4$aProduct Surveillance, Postmarketing. 615 0$aDrug monitoring$xSide effects 615 0$aAntimalarials 615 2$aDrug Monitoring 615 2$aDrug Utilization Review 615 2$aProduct Surveillance, Postmarketing 615 2$aAdverse Drug Reaction Reporting Systems 615 2$aPharmacoepidemiology 615 2$aAntimalarials 615 2$aMethods 615 2$aUtilization Review 615 2$aAntiprotozoal Agents 615 2$aInvestigative Techniques 615 2$aDrug Utilization 615 2$aPharmacology 615 2$aEpidemiology 615 2$aEvaluation Studies as Topic 615 2$aMonitoring, Physiologic 615 2$aQuality of Health Care 615 2$aQuality Assurance, Health Care 615 2$aPublic Health 615 2$aHealth Occupations 615 2$aBiological Science Disciplines 615 2$aAnalytical, Diagnostic and Therapeutic Techniques and Equipment 615 2$aDiagnostic Techniques and Procedures 615 2$aPharmacy Administration 615 2$aAntiparasitic Agents 615 2$aDisciplines and Occupations 615 2$aMedicine 615 2$aHealth Services Administration 615 2$aNatural Science Disciplines 615 2$aHealth Care Quality, Access, and Evaluation 615 2$aOrganization and Administration 615 2$aDiagnosis 615 2$aAnti-Infective Agents 615 2$aTherapeutic Uses 615 2$aHealth Care 615 2$aPharmacologic Actions 615 2$aChemical Actions and Uses 615 2$aChemicals and Drugs 615 7$aPharmacy, Therapeutics, & Pharmacology 615 7$aHealth & Biological Sciences 676 $a600 712 02$aWorld Health Organization 801 0$bAU-PeEL 801 1$bAU-PeEL 801 2$bAU-PeEL 906 $aBOOK 912 $a996320248803316 996 $aA Practical Handbook on the Pharmacovigilance of Antimalarial Medicines$92876288 997 $aUNISA