A tutorial workshop
to be held in conjunction with the
8:00 - 12:00 1:00-5:00
Sunday, 9 December 2007
San
Antonio Marriott Rivercenter
San Antonio, Texas
This workshop describes US EPA’s CatReg software for calculation of risk and benchmark concentrations (doses) by exposure duration from animal studies, and evaluation of the relationship between concentration and exposure duration on risk. It also provides for ordered severity categories of an adverse response, inclusion of user-specified variables (covariates), iterative analysis with estimation and testing of variables between and within studies, evaluation of model fit and comparison between alternatives, detection of outliers, study /data filtering, duration/concentration combinations for specified risk, and a wide range of plots. Numerous examples and several hands-on exercises are included. Attendees should bring laptops to participate in the exercises. A hard copy of the power point slides (112) and CDs with data for exercises will be provided.
Introduction (US EPA: Drs. Jeff Gift and Angela Howard)
Workshop objective
Check that all computers are correctly loaded
Dose-response (review)
Concepts and definitions (POD, RfC, RfD, etc.)
Objectives
General procedures
Illustrations
NOAEL/LOAEL
Benchmark dose
Basic features and limitations of CatReg
From data assemblage to input files to analysis
CatReg analysis for a single input file
Getting started with CatReg
Constructing an input file
Understanding and setting options
Step 1 of CatReg: estimate a response curve
Minimal input file
Add adverse severity levels to the file
Add duration of exposure (time) to the file
Add other variables (stratification) to the file
Example with continuous data
Step 2 of CatReg: responds to user requests
Estimate extra risk with confidence interval by exposure duration
Estimate concentration-time relationship with confidence interval
Test hypotheses for meta-analysis and/or model simplification
Compare model choices for best fit
Produce plots
Summary
This workshop was prepared by Dr. Kenneth G. Brown under contract to US EPA, in consultation with Drs. Jeffrey Gift and Angela Howard. It has been presented to, and vetted by, additional risk assessment experts at US EPA, and was presented at the Toxicology and Risk Assessment Conference, 2007.
Dr. Kenneth G. Brown is the principal presenter, with introduction and support from US EPA toxicologists Drs. Jeffrey Gift and Angela Howard.
Kenneth G. Brown, formerly a tenured associate professor, has 28 years of experience in quantitative health risk assessment, the last 20 as an independent consultant. He has made contributed and invited presentations at professional meetings and conferences, published in conference proceedings and refereed journals, co-authored two EPA documents, and served on several professional committees or panels. Several projects related to CatReg have been conducted for US EPA, including consultation and oversight on technical modifications and enhancements, co-authorship of the user’s manual, and publication of two articles on CatReg, one related to meta-analysis and the other to ascertaining the effect of exposure-duration on risk from applications of traditional concentration-response models. Dr. Brown holds degrees in mathematics or statistics from Duke (BA), American (MA), and Johns Hopkins (PhD) universities. A short CV is posted at www.gbaassociates.com; a longer CV is available by request (kbinc@mindspring.com).
The workshop registration fee is $225 thru November 10 and $325 on site. It is not required to register for the Annual Meeting as well to attend the workshop. Registration is handled by
Secretariat sra@burkinc.com
Society for Risk Analysis www.sra.org
1313 Dolley Madison Boulevard, Suite 402
McLean, Virginia 22101 USA
Telephone 1-703-790-1745, Fax 1-703-790-2672
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