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Consortium established to support ICH M7 compliance

An industry work-group comprising of toxicologists, pharmaceutical companies and data experts plans to unveil the early results of a data sharing project…

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An industry work-group comprising of toxicologists, pharmaceutical companies 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 ICH M7.

Led by Lhasa Limited, which creates state-of-the-art 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 harmonise AI and PDE data for commonly used reagents and solvents.

The calculation of compound specific AIs/PDEs is required in regulatory submission under various guidelines. This calculation and presentation process is often time consuming and costly, with the potential for duplicate or non-equivalent assessments across submissions from around the world.

“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 addition to the knowledge gained, the presentation of consistent limits to regulatory authorities across pharmaceutical companies has the potential to minimise the likelihood that a proposed limit would be rejected.”

The project was initiated in 2017 using Lhasa’s Vitic Nexus platform, a chemical database and information management system. Recently nine pharmaceutical companies including AstraZeneca, Boehringer Ingelheim, GSK, Novartis and Sanofi Aventis have shared AI/PDE data and, the group is now looking to expand to include new members from the pharmaceutical community.

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