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Integration of Risk Analysis and Chemical Characterization


Dr. Stephen Doherty (Director of Analytical Bioanalytical Chemistry, Toxikon)

Location: Tech Theater, Booth 637

Date: Wednesday, February 7

Time: 12:30pm - 1:15pm

Pass Type: Expo (Free), Conference (Paid) - Get your pass now!

Free Content & Activities: Tech Theater

Vault Recording: TBD

The Toxicological Risk Assessment (TRA) is an important tool in the safety assessment of biomedical devices, providing a chemical-based approach which complements a traditional animal-based testing program. The need for TRA is growing and in some cases, may be considered as a means of circumventing animal testing in the safety evaluation of devices.

Based on results of the chemical characterization, the TRA provides context to the chemistry data and the leachable compounds identified therein, which includes compounds expected to be found and compounds that are unexpected. The objective of the chemical characterization study is to identify and quantify substances that may be released from the test article during clinical use and in practical terms, is comprised of incubations of the test article in various media, e.g., water, ethanol, or hexane, at specific temperatures and durations. By considering the end use of the characterization data in the TRA during the design of the chemical characterization study it can be assured that the study provides the most useful and informative data. Considering the needs of the TRA can also help in determining appropriate detection limits for the analysis, which in turn can help in determining the amount of test material needed for the study. Further, coordinating with the risk assessment team during the design of characterization study helps ensure that the data are usable and presented in the most suitable manner. By working together, the TRA and chemical characterization study provide an understanding of the impact of potential exposures on the overall safety of a device.