Cover image for IPCS Mode of Action Framework : IPCS Harmonization Project Document No. 4.
IPCS Mode of Action Framework : IPCS Harmonization Project Document No. 4.
Title:
IPCS Mode of Action Framework : IPCS Harmonization Project Document No. 4.
Author:
Organization, World Health.
ISBN:
9789240687479
Personal Author:
Physical Description:
1 online resource (130 pages)
Contents:
BOOK COVER -- TITLE -- COPYRIGHT -- TABLE OF CONTENTS -- FOREWORD -- PART 1 IPCS FRAMEWORK FOR ANALYSING THE RELEVANCE OF A CANCER MODE OF ACTION FOR HUMANS AND CASE-STUDIES -- PREFACE -- LIST OF CONTRIBUTORS -- LIST OF ACRONYMS AND ABBREVIATIONS -- IPCS FRAMEWORK FOR ANALYSING THE RELEVANCE OF A CANCER MODE OF ACTION FOR HUMANS -- THE ROLE OF IPCS IN DEVELOPING THE FRAMEWORK FOR ANALYSING THE RELEVANCE OF A CANCER MOA FOR HUMANS -- THE 2001 IPCS CONCEPTUAL MOA FRAMEWORK FOR EVALUATING ANIMAL CARCINOGENESIS -- ADDRESSING THE ISSUE OF HUMAN RELEVANCE -- DEVELOPMENT OF AN IPCS HRF GUIDANCE DOCUMENT BASED ON THE IPCS MOA FRAMEWORK AND THE ILSI/RSI HRF -- CONCLUSIONS -- ACKNOWLEDGEMENTS -- REFERENCES -- THIAZOPYR AND THYROID DISRUPTION: CASE-STUDY WITHIN THE CONTEXT OF THE IPCS FRAMEWORK FOR ANALYSING THE RELEVANCE OF A CANCER MODE OF ACTION FOR HUMANS -- CARCINOGENICITY DATA -- POSTULATED MOA FOR THE INDUCTION OF THYROID FOLLICULAR CELL TUMOURS IN RATS -- KEY EVENTS IN EXPERIMENTAL ANIMALS -- DOSE-RESPONSE RELATIONSHIP AND CONCORDANCE -- TEMPORAL RELATIONSHIP -- STRENGTH, CONSISTENCY, AND SPECIFICITY OF ASSOCIATION OF THE TUMOUR RESPONSE WITH KEY EVENTS -- BIOLOGICAL PLAUSIBILITY AND COHERENCE -- OTHER MODES OF ACTION -- UNCERTAINTIES, INCONSISTENCIES, AND DATA GAPS -- ASSESSMENT OF POSTULATED MODE OF ACTION -- IMPLICATIONS OF THE IPCS HRF -- REFERENCES -- 4-AMINOBIPHENYL AND DNA REACTIVITY: CASE-STUDY WITHIN THE CONTEXT OF THE IPCS FRAMEWORK FOR ANALYSING THE RELEVANCE OF A CANCER MODE OF ACTION FOR HUMANS -- CARCINOGENICITY OF 4-AMINOBIPHENYL IN ANIMALS -- IS THE WEIGHT OF EVIDENCE SUFFICIENT TO ESTABLISH A MODE OF ACTION (MOA) IN ANIMALS? -- CAN HUMAN RELEVANCE OF THE MOA BE REASONABLY EXCLUDED ON THE BASIS OF FUNDAMENTAL, QUALITATIVE DIFFERENCES IN KEY EVENTS BETWEEN EXPERIMENTAL ANIMALS AND HUMANS?.

CAN HUMAN RELEVANCE OF THE MOA BE REASONABLY EXCLUDED ON THE BASIS OF QUANTITATIVE DIFFERENCES IN EITHER KINETIC OR DYNAMIC FACTORS BETWEEN EXPERIMENTAL ANIMALS AND HUMANS? -- CONCLUSION: STATEMENT OF CONFIDENCE, ANALYSIS, AND IMPLICATIONS -- 4-AMINOBIPHENYL AND THE HUMAN RELEVANCE FRAMEWORK -- ACKNOWLEDGEMENTS -- REFERENCES -- FORMALDEHYDE AND GLUTARALDEHYDE AND NASAL CYTOTOXICITY: CASE-STUDY WITHIN THE CONTEXT OF THE IPCS FRAMEWORK FOR ANALYSING THE RELEVANCE OF A CANCER MODE OF ACTION FOR HUMANS -- INTRODUCTION -- 1. IS THE WEIGHT OF EVIDENCE SUFFICIENT TO ESTABLISH A MODE OF ACTION (MOA) IN ANIMALS? -- 2. CAN HUMAN RELEVANCE OF THE MOA BE EXCLUDED ON THE BASIS OF FUNDAMENTAL, QUALITATIVE DIFFERENCES IN KEY EVENTS BETWEEN EXPERIMENTAL ANIMALS AND HUMANS? -- 3. CAN HUMAN RELEVANCE OF THE MOA BE EXCLUDED ON THE BASIS OF QUANTITATIVE DIFFERENCES IN EITHER KINETIC OR DYNAMIC FACTORS BETWEEN EXPERIMENTAL ANIMALS AND HUMANS? -- 4. STATEMENT OF CONFIDENCE, ANALYSIS, AND IMPLICATION -- REFERENCES -- PART 2 IPCS FRAMEWORK FOR ANALYSING THE RELEVANCE OF A NON-CANCER MODE OF ACTION FOR HUMANS -- PREFACE -- LIST OF CONTRIBUTORS -- LIST OF ACRONYMS AND ABBREVIATIONS -- THE NEED FOR A NON-CANCER HUMAN RELEVANCE FRAMEWORK -- WHEN WOULD THE NON-CANCER HRF BE APPLIED? -- CONSIDERATION OF THE NON-CANCER HRF -- USE OF THE FRAMEWORK AND ITS OUTPUTS -- NEXT STEPS -- REFERENCES -- THE HARMONIZATION PROJECT DOCUMENT SERIES.
Abstract:
The use of structured frameworks in chemical risk assessment promotes transparent harmonized approaches. This book presents two IPCS frameworks originally published in Critical Reviews in Toxicology in a user-friendly large format. Part 1 contains the IPCS Framework for Analysing the Relevance of a Cancer Mode of Action for Humans along with three case studies illustrating its application. Part 2 contains the IPCS Framework for Analysing the Relevance of a Non-Cancer Mode of Action for Humans. The output of a framework analysis is a clear statement of conclusions together with the confidence analysis and implications of the findings. The frameworks provide a means of ensuring a transparent evaluation of the data identification of key data gaps and of information that would be of value in the further risk assessment of the chemical in question. This book will be useful to risk assessment and regulatory institutions the chemical industry as well as to biology and toxicology scientists and researchers.
Local Note:
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2017. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
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