Chesney A, Welsh B, Kimzey A, Lansita J. The process and challenges of deriving exposure-based limits for toxicological risk assessment for components and impurities present in cell therapy products with case studies. Poster for Society of Toxicology, Virtual Annual Meeting, 2020.
A toxicology monograph requires effective identification and presentation of critical information, expertise in PDE derivation, and understanding of when a PDE calculation is not possible or necessary. A focused and complete toxicology monograph for an excipient or impurity can help set manufacturing limits, justify specification limits to a regulatory authority, and/or improve confidence in the drug product safety