LEADER 07322nam 22017293u 450 001 9910139903203321 005 20230124183120.0 010 $a9786612250057 010 $a9781282250055 010 $a1282250051 010 $a9789240683716 010 $a9240683712 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 205 $a1st ed. 210 $aGeneva $cWorld Health Organization$d2008 215 $a1 online resource (175 p.) 300 $aDescription based upon print version of record. 311 08$a9789241547499 311 08$a9241547499 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 $aDelivery of Health Care 606 $aPharmacologic Actions 606 $aChemical Actions and Uses 606 $aChemicals and Drugs 606 $aPharmacy, Therapeutics, & Pharmacology$2HILCC 606 $aHealth & Biological Sciences$2HILCC 615 4$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$aDelivery of Health Care. 615 2$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 $a9910139903203321 996 $aA Practical Handbook on the Pharmacovigilance of Antimalarial Medicines$92876288 997 $aUNINA