Computational Approaches for the Safety Assessment of Extractable and Leachable Compounds and Drug Impurities
The safety assessment of E&L compounds and drug impurities requires data on the dose of the compound received by the patient and the toxicity of the compounds; however, exposure and toxicity data are not available for many of these compounds. Fortunately, in silico computational approaches are available to predict the rate at which compounds leach from polymeric materials and predict the potential toxic hazard posed by patient exposure to these compounds.
This one-day, in-person course will provide hands on instruction on the use of computational approaches to: 1) predict the rate at which E&L compounds migrate from polymers and 2) estimate the toxicity of data-poor E&L compounds and impurities using QSAR models and Read Across approaches. The course will also explain how to use these model-derived estimates in a safety or risk assessment of E&L compounds and drug impurities.