Assessing chemical impurity and extractables and leachables (E&L) safety requires integrating mutagenicity screening with systemic toxicity information to support scientifically sound, health-based limits. As regulatory expectations evolve and chemical spaces grow increasingly complex, organisations need practical, data-driven approaches that hold up under scrutiny.
In this webinar, Instem experts Candice Johnson & Kevin Cross explore integrated approaches that combine mutagenicity prediction, toxicological evidence, and chemical similarity analysis to support defensible health-based exposure limits. You will see how Leadscope applies complementary QSAR methodologies, statistical models and expert rule-based structural alert systems, alongside the latest updates to the Leadscope bacterial mutagenicity statistical model and its expanded applicability domain. The session also covers how read-across approaches can address data gaps robustly, and how chemical similarity analysis integrates with systemic toxicity and DART data to support confident decision-making for impurity qualification and E&L safety assessment.
The session also introduces enhancements in Leadscope version 2026.0, including improved candidate analog identification and tools for documenting scientific rationale and expert judgment in regulatory submissions.
Complete the form to access this recording and discover how Leadscope and integrated data approaches help organisations derive scientifically defensible health-based exposure limits with confidence:
