Keywords:
PHYSIOLOGICALLY BASED PHARMACOKINETIC MODELS,
Project Information:
Progress
:This is a new task. However, relevant products to this research are listed under the FY2004 task 3906. The products from FY2004 are listed below; products from previous years are not included here.
ABSTRACT/ORAL
Blancato, J. Use of physiologically based pharmacokinetic models in assessments. Presented at: HEASD Seminar Series, Durham, NC, November 24, 2003.
Date Cleared: 11/23/2003 9:00:00 PM Date Presented: 11/23/2003 9:00:00 PM Peer Review Category: 3
Tracking ID: NERL-RTP-HEASD-03-195
Blancato, J., Dary, C.C., Okino, M.S., Power, F.W., Ruiz, A., and Tornero-Velez, R. Application of ERDEM in risk assessment: health effects division's risk assessor training and certification program. Presented at: Health Effects Division's Risk Assessor Training and Certification Program, Washington, DC, August 11-12, 2004.
Date Cleared: 8/9/2004 9:00:00 PM Date Presented: 8/10/2004 9:00:00 PM Peer Review Category: 3
Tracking ID: NERL-RTP-HEASD-04-105
Evans, M.V., Power, F.W., Dary, C.C., Knaak, J.B., Tornero-Velez, R., and Blancato, J. Application of the exposure dose estimating model (ERDEM) to assessment of dermal exposure in the rat to malathion. Presented at: Society of Toxicology, Baltimore, MD, March 22-26, 2004. Date Cleared: 3/24/2004 9:00:00 PM Date Presented: 3/24/2004 9:00:00 PM Peer Review Category: 3
Tracking ID: NERL-RTP-HEASD-04-038
Kryak, D.D. Demonstration of human exposure tools. Presented at: EPA Science Forum 2004, Washington, DC, June 1-3, 2004.
Date Cleared: 4/22/2004 9:00:00 PM Date Presented: 6/1/2004 9:00:00 PM Peer Review Category: 3
Tracking ID: NERL-RTP-HEASD-04-062
Lowit, A., Dary, C.C., Power, F.W., Blancato, J., Setzer, R.W., Conolly, R., and Seaton, M. Physiologically-based pharmacokinetic/pharmacodynamic modeling and cumulative risk assessment: case study for the n-methyl carbamate pesticides. Presented at: EPA Science Forum 2004, Washington, DC, June 1-3, 2004.
Date Cleared: 5/27/2004 9:00:00 PM Date Presented: 6/1/2004 9:00:00 PM Peer Review Category: 3
Tracking ID: NERL-RTP-HEASD-04-080(b)
Lowit, A., Dary, C.C., Power, F.W., Blancato, J., Setzer, R.W., Conolly, R., and Seaton, M. Physiologically-based pharmacokinetics/pharmacodynamic modeling and cumulative risk assessment: case study for the n-methyl carbmate pesticides. Presented at: EPA Science Forum 2004, Washington, DC, June 1-3, 2004.
Date Cleared: 5/27/2004 9:00:00 PM Date Presented: 6/1/2004 9:00:00 PM Peer Review Category: 3
Tracking ID: NERL-RTP-HEASD-04-080(a)
Okino, M.S., Power, F.W., Blancato, J.N., Chiu, W., Chen, C., and Lipscomb, J. Harmonization and communication of PBPK models using the exposure related dose model (ERDEM) system: trichloroethylene. Presented at: EPA Science Forum 2004, Washington, DC, June 1-3, 2004.
Date Cleared: 4/8/2004 9:00:00 PM Date Presented: 6/1/2004 9:00:00 PM Peer Review Category: 3
Tracking ID: NERL-RTP-HEASD-04-050(a)
Okino, M.S., Power, F.W., Blancato, J., Chiu, W., Chen, CW, and Lipscomb, J. Harmonization and communication of PBPK models using the exposure related dose estimation model (ERDEM) system: trichloroethylene. Presented at: EPA Science Forum 2004, Washington, DC, June 1-3, 2004.
Date Cleared: 5/12/2004 9:00:00 PM Date Presented: 6/1/2004 9:00:00 PM Peer Review Category: 3
Tracking ID: NERL-RTP-HEASD-04-050(b)
Ross, M.K., Tornero-Velez, R., Granville, C., Gold , A., Evans, M.V., and DeMarini, D. M. Metabolism of 1,1- and 1,3- dichloropropene: a mechanism of bioactivation by glutathione. Presented at: International Society for the Study of Xenobiotics, Vancouver, Canada, August 29-September 2, 2004.
Date Cleared: 4/25/2004 9:00:00 PM Date Presented: 8/30/
Relevance
:Exposure related physiologically-based pharmacokinetic (PBPK) and pharmacodynamic (PBPD) models as developed in ERDEM hold the very real promise of aiding risk assessors and policy experts in making informed judgements about the scientific validity of safety factors, reference doses (RfD), and margin of exposure (MOE). As a matter of policy, pesticide cumulative risk assessments rely on a ?weight of the evidence? approach (U.S. EPA, http://www.epa.gov/pesticides/cumulative/). Recently, the Office of Pesticide Programs (OPP) FIFRA science advisory panel (SAP) recognized the usefulness of computational software for the assessment of aggregate exposure and cumulative risk to pesticides having a common mechanism of toxicity (Federal Register. 4/17/2002; Federal Register. 10/22/2003; http://www.epa.gov/scipoly/sap/). The 10/222003 FIFRA SAP commended U.S. EPA for the initiative to develop a much needed methodology and tool for refining health risk in general and cumulative risk in particular. The SAP acknowledged the urgent need for PBPK/PD model development for use in cumulative risk assessment. The report, ?Physiologically-based pharmacokinetic (PBPK) and pharmacodynamic (PBPD) modeling: Preliminary evaluation and case study for the N-methyl carbamate pesticides: A consultation?, (FIFRA SAP 12/11-12, 2003) stated that EPA is on the right track to find a workable, manageable and acceptable solution to a pressing issue in risk assessment. For these reasons, external advisors to NCEA and OPPTS/OPP have recommended the use of PBPK models in risk assessments, in conjunction with ?weight-of- the-evidence? procedures, to formulate state-of-the science analyses. Moreover, it is simply not practical for the Agency to collect data to address every aspect of the exposure to risk paradigm. This is particularly true for exposures involving multiple chemicals or mixtures. It is therefore prudent and necessary to enable PBPK/PD models to predict risk to diverse populations for exposure scenarios where a multiplicity of pathways impose ponderous uncertainties upon non-computational ?weight-of- the-evidence? procedures.
Clients
:OPPTS, OPP, OSWER, ORD, NERL, NCEA, NHEERL, Scientific Community
Project IDs:
ID Code
:20709
Project type
:OMIS