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Toxicological Risk Assessment Based on Extractable/Leachable (E/L) Data: Benefits and Limitations

November 9, 2016 @ 11:00 am - 12:00 pm

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

This webinar will discuss the collection of E/L data that are useful and relevant to risk assessment. Designing an E/L analysis requires one to consider not only the nature of the device and its constituent materials, but also the consumer/patient exposure, including the duration of expected exposure. One of the greatest uncertainties currently plaguing the risk assessment of medical devices is in the use of data from a single extraction (24-72 hours) and the (forced) assumption that the leaching of each analyte will (or will not) continue for the duration of the exposure period. However, this shortcoming of the data can be avoided with proper study design. Other potential pitfalls in the E/L analysis and the use of these data in risk assessment will be described, with the most important points being highlighted with several case studies. Participants will learn to recognize the most common pitfalls in E/L analysis as used in risk assessment and learn to avoid them.


November 9, 2016
11:00 am - 12:00 pm
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