Exposure-response relationship applications

Food and Drug Administration. Guidance for Industry Exposure-Response Relationship, Study Design, Data Analysis, and Regulatory Applications, April 2003 (posted May 2003). Available at http //www.fda.gov/cder/. Accessed October 6, 2006. 

FDA Administration. Guidance for Industry Exposure-Response Relationships -Study Design, Data Analysis, and Regulatory Applications, 2003. 

Archer V, Radford E, Axelson O. 1979. Radon daughter cancer in man factors in exposure-response relationships at low levels. In Conference workshop on lung cancer epidemiology and industrial applications of sputum cytology. Golden, CO Colorado School of Mines... 

FDA Guidance for Industry. 2003. Exposure-response relationships— Study design, data analysis, and regulatory applications. Washington, DC U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologies Evaluation and Research (CBER). 

FIGURE S.6 Schematic illustration of the traditional setting of an acceptable level of exposure (ADI) by dividing the NOAEL from an animal study by an assessment factor (AF). The two dose-response relationships have identical NOAEL. If a uniform assessment factor is applied, there will be an adequate MOS at the ADI for effect b but not for effect a. (Modified from KEMI, Human health risk assessment. Proposals for the use of assessment (uncertainty) factors. Application to risk assessment for plant protection products, industrial chemicals and biocidal products within the European Union. Report No. 1/03, Solna, Sweden, 2003. 

By examination of the organ-specific ratios of calculated doses to allowable doses obtained in the previous step, the maximum value of these ratios is selected. Application of the MAX function to these organ-specific ratios is based on an assumption that induction of deterministic responses in any organ is independent of doses in any other organs or, equivalently, that the threshold in the dose-response relationship for any substance that causes deterministic responses is not affected by exposure to multiple... 

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