Weight of Evidence Approaches for DART Assessments of Oligonucleotides: Current Reality and Future Considerations
This presentation focuses on the regulatory expectations for the Developmental and Reproductive Toxicity (DART) assessment of oligonucleotide-based therapeutics (ONTs). The presentation provides a high-level introduction to ONTs, their structures and modes of action as well as the existing guidance related to the investigation of DART risk for these agents. While existing guidance primarily supports the use of WoE approaches when DART risk seems likely, ONTs have attributes that could conceivably allow for greater use of WoE assessments in establishing negligible risk for DART in some instances, potentially reducing or eliminating the need for product-specific DART assessments. This presentation discusses these attributes and potential scenarios that would benefit from an ONT-specific application of WoE to the DART assessment.
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