In Silico & Data Insights Blog
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Why Applicability Domain Matters in (Quantitative) Structure-Activity Relationship (Q)SAR Models: Supporting Interpretation in Mutagenicity Assessments
Instem Team
Understand how applicability domain affects QSAR prediction confidence and why chemical coverage matters when assessing pharmaceutical impurities under ICH M7.
Mutagenicity Assessment Under ICH M7: Scientific Principles Supporting Pharmaceutical Impurity Risk Assessment
Instem Team
Mutagenicity assessment is the critical first step in pharmaceutical impurity risk evaluation, and this blog explores the scientific principles underpinning robust ICH M7 assessments, from complementary QSAR methodologies and Ames study data to applicability domain...
Strengthening CMC Readiness with In Silico Insight
Instem Team
CMC readiness begins long before IND submission. Explore how early data-driven decision-making, predictive toxicology, and connected workflows can reduce risk, improve data quality, and simplify regulatory preparation throughout the drug development journey.
Advancing Risk-Based E&L Safety Assessment: The Role of ICH Q3E and Leadscope
Jignyasa Bal
As ICH Q3E advances a risk-based paradigm for E&L safety, the question is shifting from whether to assess risk toward how to do it consistently across a vast and diverse chemical space. Leadscope enables structure...
Leadscope Model Applier™ v2026 – Expanding confidence in predictive toxicology
Jignyasa Bal
This release introduces advanced predictive models and extensive toxicological data to support rigorous chemical safety assessments.
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