1.

Record Nr.

UNINA9910139903203321

Titolo

A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines [[electronic resource]]

Pubbl/distr/stampa

Geneva, : World Health Organization, 2008

ISBN

1-282-25005-1

9786612250057

92-4-068371-2

Descrizione fisica

1 online resource (175 p.)

Disciplina

600

Soggetti

Adverse Drug Reaction Reporting Systems

Antimalarials -- standards

Antimalarials

Drug Monitoring

Drug Utilization Review -- methods

Pharmacoepidemiology -- methods

Product Surveillance, Postmarketing

Drug monitoring - Side effects

Drug Utilization Review

Pharmacoepidemiology

Methods

Utilization Review

Antiprotozoal Agents

Investigative Techniques

Drug Utilization

Pharmacology

Epidemiology

Evaluation Studies as Topic

Monitoring, Physiologic

Quality of Health Care

Quality Assurance, Health Care

Public Health

Health Occupations

Biological Science Disciplines

Analytical, Diagnostic and Therapeutic Techniques and Equipment

Diagnostic Techniques and Procedures

Pharmacy Administration

Antiparasitic Agents



Disciplines and Occupations

Medicine

Health Services Administration

Natural Science Disciplines

Health Care Quality, Access, and Evaluation

Organization and Administration

Diagnosis

Anti-Infective Agents

Therapeutic Uses

Delivery of Health Care

Pharmacologic Actions

Chemical Actions and Uses

Chemicals and Drugs

Pharmacy, Therapeutics, & Pharmacology

Health & Biological Sciences

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di contenuto

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 TERMS

ANNEX 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

Sommario/riassunto

""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