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.
This webinar explores integrated, data-driven approaches that combine mutagenicity prediction, toxicological evidence, and chemical similarity analysis to support scientifically defensible health-based exposure limits.
What You Will Learn
Advancing Mutagenicity Assessment
- Application of two complementary quantitative structure–activity relationship methodologies: statistical models and expert rule-based structural alert systems
- Interpretation of predictions with consideration of applicability domains and mechanistic relevance
- Scientific rationale behind recent updates to the Leadscope bacterial mutagenicity statistical model
- How expanded applicability domain improves coverage of previously out-of-domain chemical structures
From Non-Mutagenic Findings to Risk Assessment Decisions
- Evaluation of toxicological evidence for compounds exceeding safety thresholds
- Determining when compound-specific data supports direct derivation of health-based exposure limits
- Applying read-across approaches to address data gaps in a scientifically robust manner
Strengthening Read-Across and Data Integration
- Best practices for assessing structural, physicochemical, and toxicological similarity
- Transparent characterization and communication of uncertainty
- Interpretation of supporting study data to inform regulatory decisions
Leveraging Advanced Tools and Data Integration
- Overview of enhancements in Leadscope version 2026.0
- Integration of chemical similarity analysis with systemic toxicity and developmental and reproductive toxicity data
- Identification and evaluation of candidate analogs for read-across
- Documenting scientific rationale and expert judgment in regulatory submissions
Scientific Value
This session highlights how:
- Computational predictions, chemical similarity analysis, and toxicological evidence can be combined effectively
- Expert scientific review enhances transparency and reproducibility
- Integrated approaches support confident decision-making for impurity qualification and extractables and leachables safety assessment
- Health-based exposure limits can be derived using scientifically defensible methodologies
Who Should Attend
This webinar is designed for professionals involved in:
- Toxicology and safety assessment
- Regulatory science and compliance
- Pharmaceutical and biopharmaceutical development
- Medical device safety and extractables and leachables evaluation
- Risk assessment and product stewardship
Why Attend?
Strengthen your ability to derive and justify health-based limits with confidence
Gain insight into current scientific and regulatory expectations
Understand practical strategies for data-limited scenarios
Explore advanced tools supporting modern risk assessment workflows
