Yi Yu-Rice, Ph.D., DABT, is a pharmaceutical and medical device toxicologist with extensive experience in designing and evaluating studies to support global device registration. They have a strong background in ISO 10993 standards, GLP and GMP regulations, and various toxicological assessment guidelines. Currently a Senior Principal Scientist at Amgen, Yi manages toxicology assessments related to extractables and leachables for drug-device combination products. Previously, they held positions at Edwards Lifesciences and Amway, contributing to biocompatibility evaluations and regulatory submissions. Yi earned a Ph.D. in Pharmacology from Rush University and has published multiple scientific manuscripts throughout their career.
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