Committee on the Use of Third Party Toxicity Research with Human Research Participants Science, Technology, and Law Program, National Research Council

• 1 Front Matter; 2 Executive Summary and Recommendations; 3 1 Introduction and Background; 4 2 The Regulatory Framework for Protecting Humans in Research; 5 3 Scientific Justification for and Conduct of Intentional Human Dosing Studies; 6 4 A Risk-Benefit Framework for Assessing Intentional Human Dosing Studies; 7 5 Ethical Considerations in the Review of Intentional Human Dosing Studies; 8 6 Procedures for EPA Review of Intentional Human Dosing Studies; 9 7 EPA's Use of Data from Intentional Human Dosing Studies in Risk Assessment; 10 Appendix A: Values and Limitations of Animal Toxicity Data; 11 Appendix B: Pharmacokinetics and Metabolism of Pesticides; 12 Appendix C: Biographical Sketches of the Members and Staff of the Committee on the Use of Third Party Toxicity Research with Human Research Participants; 13 Appendix D: Biographical Sketches of the Members of the Science, Technology, and Law Panel; 14 Appendix E: Meeting Agendas; 15 Appendix F: Combined Registrants List for All Meetings

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Committee on the Use of Third Party Toxicity Research with Human Research Participants Science, Technology, and Law Program, National Research Council

• 1 Front Matter; 2 Executive Summary and Recommendations; 3 1 Introduction and Background; 4 2 The Regulatory Framework for Protecting Humans in Research; 5 3 Scientific Justification for and Conduct of Intentional Human Dosing Studies; 6 4 A Risk-Benefit Framework for Assessing Intentional Human Dosing Studies; 7 5 Ethical Considerations in the Review of Intentional Human Dosing Studies; 8 6 Procedures for EPA Review of Intentional Human Dosing Studies; 9 7 EPA's Use of Data from Intentional Human Dosing Studies in Risk Assessment; 10 Appendix A: Values and Limitations of Animal Toxicity Data; 11 Appendix B: Pharmacokinetics and Metabolism of Pesticides; 12 Appendix C: Biographical Sketches of the Members and Staff of the Committee on the Use of Third Party Toxicity Research with Human Research Participants; 13 Appendix D: Biographical Sketches of the Members of the Science, Technology, and Law Panel; 14 Appendix E: Meeting Agendas; 15 Appendix F: Combined Registrants List for All Meetings

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Committee on the Use of Third Party Toxicity Research with Human Research Participants Science, Technology, and Law Program, National Research Council

• 1 Front Matter; 2 Executive Summary and Recommendations; 3 1 Introduction and Background; 4 2 The Regulatory Framework for Protecting Humans in Research; 5 3 Scientific Justification for and Conduct of Intentional Human Dosing Studies; 6 4 A Risk-Benefit Framework for Assessing Intentional Human Dosing Studies; 7 5 Ethical Considerations in the Review of Intentional Human Dosing Studies; 8 6 Procedures for EPA Review of Intentional Human Dosing Studies; 9 7 EPA's Use of Data from Intentional Human Dosing Studies in Risk Assessment; 10 Appendix A: Values and Limitations of Animal Toxicity Data; 11 Appendix B: Pharmacokinetics and Metabolism of Pesticides; 12 Appendix C: Biographical Sketches of the Members and Staff of the Committee on the Use of Third Party Toxicity Research with Human Research Participants; 13 Appendix D: Biographical Sketches of the Members of the Science, Technology, and Law Panel; 14 Appendix E: Meeting Agendas; 15 Appendix F: Combined Registrants List for All Meetings

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