Director of Toxicology & Quality Services PharmEng Technology Durham, North Carolina, United States
Products to treat eye diseases and neurological diseases require novel routes of administration. There may be adequate weight of evidence of toxicological risks of residual solvents in products with routes of administration, such as an IV infusion, but what is the toxicological risk of residual solvents of a final product injected directly into the brain? This talk will present a case study to address the amounts and toxicity of residual manufacturing reagents in a final product directly injected into the brain. The audience will be asked about creating permitted daily exposure (PDE) values of residual solvents or impurities and how best to present the information to Health Authorities. Learning objectives: 1) understand the approach to determine PDEs for residual solvents or impurities, 2) understand that some chemicals may require surrogates to adequately address toxicological risk, and 3) understand that each product is evaluated on a case-by-case basis and adequate weight evidence is required to show toxicological risk of residual solvents or impurities in a final product.
