Publications : 2019

Mihalchik-Burhans AL, Sullivan DW. 2019. Bridging issues of route. In: Gad S (ed), Integrated Safety and Risk Assessment for Medical Devices and Combination Products, pp. 273–297. Springer.


Excerpt from Abstract:  Current regulatory guidelines call for the identification and quantification of chemical compounds [that] may migrate out of a medical device, combination product, or a drug container closure system, and into an individual. Compounds that migrate from these devices often have little available toxicity data[,] resulting in a major challenge in performing an adequate assessment of biological or toxicological risks and thes potentially compromising patient safety. These limited toxicity data may exist by alternative routes. Here we discuss the factors to consider when performing route-to-route extrapolations…