Human Risk Assessment

Roloff\, M V

• 1. Animal selection and extrapolation – the problem defined Part I: Current industrial practices and regulatory status of animal selection and extrapolation 2. Current EPA perspectives on animal selection and extrapolation 3. Current FDA perspectives on animal selection and extrapolation 4. International perspectives on animal selection and extrapolation 5. Opinions on animal selection for the assessment of carcinogenicity Part 2: Use of physiological and toxicological data from man and animals as aids in animal selection and extrapolation 6. Anatomical and physiological considerations in species selections — animal comparisons 7. The role of diet and nutrition in safety evaluation of drugs and other chemicals 8. The role of clinical pathology in the selection of animal species 9. Species differences in toxic lesions Part 3: Metabolic and pharmacokinetic considerations in species selection 10. Retrospective evaluation of appropriate animal models based on metabolism studies in man 11. The role of studies of absorption, metabolism, distribution and elimination in animal selection and extrapolation 12. Physiologically based pharmacokinetics and methylene chloride cancer risk assessment considerations 13. Route of exposure: An important consideration in animal selection and the design of toxicity studies Part 4: Animal selection considerations in carcinogenic and reproductive toxicity 14. The short-term assays: The challenges and problems of adolescence 15. Testing procedures to define carcinogens as human cancer risks 16. Risk assessment considerations for the reproductive and developmental toxicity of oestrogenic xenobiotics 17. Selection of animals for reproductive toxicology studies: An evaluation of selected assumptions in reproductive toxicity testing and risk assessment Part 5: Pharmacogenetic and human monitoring considerations in animal selection 18. Pharmacogenetic considerations in the selection of appropriate animal models in teratology 19. Pharmacogenetic differences between humans and laboratory animals: Implications for modelling 20. Studies of cellular reaction to toxicity in human cells and tissues: Extrapolation of animal data to man 21. Problems and prospects in inter-species extrapolation Summary 22. Selection and extrapolation – the task of implementation