Harmonisation of read-across methodology for drug substance extractables and leachables (E & amp;Ls)

In conclusion, an E&L read-across methodology has been developed to provide a consistent, health protective framework for deriving HBELs when toxicology data is limited.PMID:37748702 | DOI:10.1016/j.yrtph.2023.105494

Source: Regulatory Toxicology and Pharmacology : RTP - September 25, 2023 Category: Toxicology Authors: Melisa Masuda-Herrera Hannah T Rosen Anders Burild Thomas Broschard Troy Griffin Tyler Bell Jessica Graham Jedd Hillegass Penny Leavitt Brian Huta Trish Parris Uma Bruen Maureen Cruz Joel Bercu Source Type: research