September 27-28, 2023 | Annapolis, Maryland
WuXi AppTec is proud to be exhibiting at Biocompatibility Insights on September 27-28, 2023.
About Biocompatibility Insights
Limulus Bio is proud to present Biocompatibility Insights 2023, a two-day conference created to inspire, educate and network. Biocompatibility Insights is a conference focusing solely on biocompatibility and toxicology for medical devices, with the aim to bring people together to inspire, educate and network. The framework for the conference series is “The Science Behind the Regulations” and sub-theme for this year’s conference “Addressing Challenges in Medical Device Toxicology”.
Dr. Kim Ehman, Director of Regulatory Toxicology and Consulting, WuXi AppTec
Date: September 27th, 2023
Use of simulated-use extractable studies to refine exposure estimation for toxicology risk assessments
Toxicological risk assessments identify any potential risk to patients from the chemical constituents of a medical device product detected through a series of extraction tests. Exaggerated and exhaustive extractions often lead to overly conservative TRAs with unfavorable conclusions around potential risk. When MOS values are <1, simulated-use studies provide a profile of release kinetics that allow for refinement of exposure assumptions in the TRA.
This session will discuss:
- An overview of the various factors and challenges with each extraction technique
- How simulated-use extractions work
- Regulatory feedback on each extraction approach