Mass Transport Modelling in support of leachable risk management.

Leachable risk management continues to be of regulatory interest. However, we continue to rely on experimental extractable studies as predictors of leachable risk. These are complex to design and implement and do not always offer the answer to what is the leachable risk for a drug product or medical device. We hope to show that mass transport modeling provides an alternative or a complementary element to testing the leachable risk.
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