Industry Workgroup Examines Exposure Limit Data

An industry workgroup made up of pharmaceutical companies, toxicologists, and data experts plans to unveil the early results of a data sharing project designed to enhance the safety of drug substances and aid compliance with quality guidelines, such as International Council for Harmonization (ICH) M7.

Led by Lhasa, an educational charity which creates in-silico prediction and database systems, the Acceptable Intake (AI) and Permitted Daily Exposure (PDE) project has brought together a team of individuals to share and harmonize project data for commonly-used reagents and solvents. 

The calculation of compound specific AIs/PDEs is required in regulatory submission under various guidelines, including ICH M7 and ICH quality guidelines A, B, and C (Q3A/B/C). This calculation and presentation process can be consuming and costly, with the potential for duplicate or non-equivalent assessments across submissions from around the world.

The project was initiated in 2017 using the charity’s Vitic Nexus platform, a chemical database and information management system. Nine pharmaceutical companies, including AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, and Sanofi Aventis have shared project data. Currently, the group is looking to expand to include new members from the pharmaceutical community.

“One benefit of the AI/PDE project is that participants may gain access to a set of acceptable exposure limits for chemicals common to the synthesis of pharmaceuticals,” said Krista Dobo, senior director of drug safety R&D at Pfizer, in a company press release. “In addition to the knowledge gained, the presentation of consistent limits to regulatory authorities across pharmaceutical companies has the potential to minimize the likelihood that a proposed limit would be rejected.”

Source: Lhasa