The FDA ICH S1B (R1) guidance introduces a Weight of Evidence (WoE) approach for assessing human carcinogenic risk in drug development, aiming to replace traditional two-year rat carcinogen
The FDA ICH S1B (R1) guidance introduces a Weight of Evidence (WoE) approach for assessing human carcinogenic risk in drug development, aiming to replace traditional two-year rat carcinogenicity studies. This innovative framework integrates data from diverse sources, including in vitro, animal, and clinical studies, while focusing on six key WoE factors: target biology, secondary pharmacology, chronic histopathology, hormonal perturbation, genotoxicity, and immune modulation. Together, these factors offer a comprehensive and interconnected perspective on carcinogenic risk.
In this webinar, discover how Eurofins Discovery has developed a comprehensive WoE platform using advanced in vitro methods. Key innovations include molecular target evaluations to detect non-genotoxic carcinogens, nuclear hormone receptor panels for assessing hormonal perturbation, and genotoxicity assays such as ames and micronucleus tests.
Plus, find out how cutting-edge BioMAP technology provides insights into immune and hormonal safety profiles, while an AI-driven cell transformation assay (CTA) evaluates carcinogen-induced malignant phenotypes with precision.
Results demonstrate that the carcinogenicity risk assessment panel effectively identifies diverse carcinogens and their mechanisms. AI-enhanced image analysis in the Bhas 42 CTA boosts efficiency and objectivity. This approach enables early detection of carcinogenic liabilities, aligns with ICH S1B(R1) guidelines, and offers a humane, streamlined alternative to traditional two-year rat studies.
Watch video for free
Login or Become a member
- Unlock access to exclusive content
- Save content for easy viewing later
- Set your preferences for tailored content
- Save your details for quick downloads
- Create your own project research collections
Key Discussion Points
- Understand the Weight of Evidence (WoE) approach and its role in modern carcinogenicity risk assessment.
- Explore the six critical WoE factors that provide comprehensive insights into carcinogenic risks.
- Discover innovative in vitro alternatives to animal testing for ethical and efficient drug development.
FAQs
Yes – there is no charge to watch the webinar, either live or on-demand.
The webinar will take place live on 13 November at 2pm GMT
The webinar will become available to watch on-demand shortly after the live webinar takes place.
