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.
本ウェビナーでは、変異原性予測、毒性学的エビデンス、および化学的類似性分析を組み合わせた、統合的かつデータ駆動型のアプローチについて解説し、科学的に正当化可能な健康に基づく曝露限度値の策定を支援します。
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
