Melisa Masuda-Herrera

Day 2: Thursday, 12 October 2023

CASE STUDY: Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTC) for Parenteral Extractables and Leachable

• The ELSIE consortium derived duration-based, non-mutagenic thresholds of toxicological concern (TTCs) for parenteral extractables and leachables substances.
• The first part of the presentation will provide a brief background on the ELSIE consortium and the ELSIE Risk Management Framework for extractables and leachable assessments.
• This will be followed by a general overview of the TTC concept and its application to mutagenic and non-mutagenic impurities.
• A majority of the presentation will then focus on the process for deriving the duration-based TTCs for parenteral E&Ls, including an overview of the ELSIE database, evaluation of the toxicological data used to determine the parenteral point of departuand application of adjustment factors.