For your medical device study designs and protocols, our scientists build in the most effective in-vivo or in-vitro model to meet the study goals and stay compliant with governing laws, including the Animal Welfare Act (AWA) when applicable.
At an international level, ISO 10993 working groups, including participants from WuXi AppTec, are challenged to find alternatives to existing in-vivo models as well as ways to meet study endpoints in new and creative ways to reduce current requirements. At the same time, these working groups must ensure that any alternative model or reduction in requirements does not impact the scientific outcomes of the study or, at a minimum, demonstrates equivalency.
For example, in the latest update to ISO 10993-Part 11: Tests for Systemic Toxicity, which was released in September 2017, the dual route model was introduced. It is a new method for evaluation of subchronic toxicity outlined in an informative Annex (H) of Part 11.
The new dual route model combines administration of polar and nonpolar extracts into the same animal concurrently and is appropriate for medical devices that are not intended for implantation and where dosing by extracts is an option. The model may not be appropriate when there is a need to study the administration routes separately.
The method utilizes intravenous dosing daily for 14 days and intraperitoneal dosing 5 of the 14 days in a rodent in-vivo model. This more closely simulates the clinical experience and a worst-case scenario of total extractables exposure. The method also reduces the total number of animals needed for evaluation when compared to running two separate studies for polar and nonpolar subacute/subchronic exposure systemic toxicity evaluations.
For more information about how our experienced working group can work effectively for your medical device testing, contact us.