Leadscope Model Applier

Leadscope Model Applier is a sophisticated software solution designed for in silico toxicology prediction, offering precise assessments of toxicology endpoints. It provides comprehensive support by delivering predictions, enabling expert reviews, and producing regulatory-compliant reports quickly and efficiently.

Through collaboration with the FDA, over 100 predictive models have been developed, incorporating a vast database of over 600,000 studies on more than 200,000 chemicals, ensuring robust and transparent toxicity assessments. This integration significantly reduces the reliance on costly animal and in vitro studies, streamlining safety evaluations in pharmaceutical development and chemical risk assessment.

Key advantages of the software include generating regulatory-ready predictions conforming to ICH M7 guidelines and other international standards. Its transparent models help users understand the basis of predictions, compare structural analogs, and justify results confidently.

• Regulatory-Ready Predictions: Supports ICH M7 and global guidelines with reports formatted to meet regulatory expectations.
• Transparent Models: Offers clarity in reviewing prediction rationales and results.
• Flexible and User-Friendly: Users can input chemical structures via various formats, process them individually or in batches quickly.
• Unmatched Data Access: Access to one of the largest toxicity databases with curated and reliable data.
• Time and Cost Efficiency: Reduces the need for traditional laboratory studies, aligning with the 3Rs.
• Continuous Updates: Regular model updates ensure the latest scientific advancements in line with OECD standards.

The software incorporates core features including a robust ICH M7 module for impurity assessment, enhanced skin sensitization models, and a comprehensive acute oral toxicity solution suitable for cross-industry evaluations. It also features a metabolism suite for predicting metabolic liabilities and interactions, and a N-Nitrosamine CPCA module for evaluating pharmaceutical safety.