Read Across Assessment for Potential Leachables Without Toxicological Data

The pharmaceutical industry acknowledges the potential for compounds to leach at low levels into drug products from manufacturing and packaging systems. Evaluating the stability, quality, and safety of materials used for packaging systems and manufacturing components is an important aspect of the drug development process.

If potential leachables exceed established safety thresholds but lack toxicity data, in silico models and the Extractables and Leachables Safety Information Exchange (ELSIE) non-mutagenic parenteral thresholds of toxicological concern (TTCs) may be used to inform the toxicological assessment (ICH M7 (R1), 2017; Chilton et al, 2022; Masuda-Herrera et al. , 2023; Parris et al, 2022; Parris et al, 2023).