COVER -- TITLE -- COPYRIGHT -- CONTENTS -- NOTE TO READERS OF THE CRITERIA MONOGRAPHS -- PREAMBLE -- Objectives -- Scope -- Procedures -- WHO PLANNING GROUP FOR THE IPCS HARMONIZATION PROJECT ON DOSE-RESPONSE MODELLING -- WHO TASK GROUP ON ENVIRONMENTAL HEALTH CRITERIA ON PRINCIPLES FOR MODELLING DOSE-RESPONSE FOR THE RISK ASSESSMENT OF CHEMICALS -- PREFACE -- ACRONYMS AND ABBREVIATIONS -- 1. SUMMARY, CONCLUSIONS, AND RECOMMENDATIONS -- 1.1 Summary -- 1.2 Conclusions -- 1.3 Recommendations -- 2. INTRODUCTION -- 2.1 Background -- 2.2 Scope -- 3. RISK ANALYSIS -- 3.1 Decision paradigms -- 3.2 Risk analysis paradigms -- 3.3 Motivations and considerations for producing a formal risk assessment -- 3.3.1 Transparency and justification -- 3.3.2 Public health and individual health -- 3.3.3 Quantification and computation -- 3.3.4 Cost of assessment -- 3.4 Risk assessment -- 3.4.1 Problem formulation -- 3.4.2 Risk assessment outcomes -- 4. DOSE-RESPONSE MODELLING: BASIC CONCEPTS -- 4.1 Introduction -- 4.2 What is dose? -- 4.3 What is response? -- 4.4 What is a model? -- 4.5 What is dose-response modelling? -- 4.6 Risk versus safety in dose-response modelling -- 4.7 Summary -- 5. DOSE-RESPONSE MODELLING: WHY AND WHEN TO USE IT -- 5.1 Historical perspectives -- 5.1.1 The no-observed-adverse-effect level approach to acceptable/tolerable daily intake -- 5.1.2 The benchmark dose approach to acceptable/tolerable daily intake -- 5.2 Points of consideration -- 5.2.1 General aspects of definition -- 5.2.2 Estimation procedure -- 5.2.3 Uncertainty -- 5.2.4 Study design -- 5.2.5 Biological information -- 5.2.6 Comparison of experimental results -- 5.2.7 Risk management perspectives -- 5.3 Implementation issues -- 5.4 Summary -- 6. PRINCIPLES OF DOSE-RESPONSE MODELLING -- 6.1 Data -- 6.1.1 Selection of data -- 6.1.2 Data types -- 6.2 Models and distributions.

6.2.1 Dose-response models -- 6.2.2 Statistical distributions -- 6.3 Model fitting and estimation of parameters -- 6.3.1 Criterion function -- 6.3.2 Search algorithms -- 6.4 Model comparison -- 6.5 Representing uncertainty -- 6.5.1 Sampling error -- 6.5.2 Study error -- 6.5.3 Model error -- 6.6 Benchmark dose and benchmark response selection -- 6.7 Summary -- 7. COMMUNICATING THE RESULTS OF DOSE- RESPONSE MODELLING -- 7.1 Introduction -- 7.2 Incorporation of the outputs of dose-response modelling into risk assessment -- 7.3 Derivation of health-based guidance values -- 7.4 Estimation of the margin of exposure -- 7.5 Quantitative estimations of the magnitude of the risk at levels of human exposure -- 7.6 Presentation of results -- 7.6.1 Tables -- 7.6.2 Graphs -- 7.7 Risk assessment context and questions -- 7.8 Synopsis of approach to modelling -- 7.8.1 Data sets -- 7.8.2 Uncertainty -- 7.9 Explaining/interpreting the output of the dose-response analysis -- 7.9.1 Outputs in the observable biological range -- 7.9.2 Outputs outside the observable biological range -- 7.10 Issues for risk managers -- 7.10.1 Risk assessment issues -- 7.10.2 Risk management issues -- 8. CONCLUSIONS AND RECOMMENDATIONS -- 8.1 Conclusions -- 8.2 Recommendations -- REFERENCES -- ANNEX 1: TERMINOLOGY -- RESUME, CONCLUSIONS ET RECOMMANDATIONS -- 1. Résumé -- 2. Conclusions -- 3. Recommandations -- RESUMEN, CONCLUSIONES Y RECOMENDACIONES -- 1. Resumen -- 2. Conclusiones -- 3. Recomendaciones -- THE ENVIRONMENTAL HEALTH CRITERIA SERIES -- CONCISE INTERNATIONAL CHEMICAL ASSESSMENT DOCUMENT SERIES.