Charge the SAP for the October 24-27 2017 Meeting on Physiologically Based Pharmacokinetic Modeling to Address Pharmacokinetic Differences Between and Within Species
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چکیده
The 2009 National Research Council report “Science and Decisions”1 recommends that the agency uses the best, most current science, to support or revise the default assumptions in the agency’s risk assessments. In addition, the 2013 Institute of Medicine report on “Environmental Decisions in the Face of Uncertainty”2 further recommends replacing default uncertainty factors with data-derived extrapolation factors (DDEFs) that delineate the differences between and within species, which would decrease uncertainty in risk assessment. DDEFs for interand intra-species extrapolation can be estimated using physiologically based pharmacokinetic (PBPK) modeling to organize data that describe the absorption, distribution, metabolism, and excretion (ADME) of chemicals that enter the body.
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