Lhasa Limited is pleased to announce the release of Acrostic, a cutting-edge read-across tool designed to enhance decision-making in establishing acceptable intake (AI) limits for novel and untested nitrosamines.
In line with the risk-based safety assessment framework issued by regulatory authorities such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and Health Canada, Acrostic serves as a valuable resource to support and document the read-across assessments recommended in this guidance, which yield compound-relevant AI limits for nitrosamines with suitable analogues, complementing the CPCA approach.
Leveraging a comprehensive set of data and expert knowledge, including relevant assay data, toxicophore knowledge, and physico-chemical properties, Acrostic assembles this information into a logical and intuitive workflow for surrogate selection. This enables users to robustly and confidently assign a carcinogenic potency value to target compounds.
Dr. Adrian Fowkes, Director of Science at Lhasa is excited about the launch, stating “Acrostic represents a significant advancement in risk assessment methodologies through its purposeful workflows for evaluating nitrosamine carcinogenicity. We believe Acrostic will play a pivotal role in supporting regulatory compliance and ensuring the safety of pharmaceuticals and other chemical products.”
Would you like to find out more about Acrostic? Visit Lhasa’s nitrosamine impurity risk assessment page.
Catch up on the Lhasa read-across masterclass to facilitate AI limit setting for nitrosamines.