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11 Oct 2023
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.
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