Integrating Human Intestinal Organoids into FDA'S New Approach Methodologies for Drug Discovery - PubMed
5 hours ago
- #FDA NAMs
- #drug discovery
- #organoids
- Human intestinal organoids (HIOs) are emerging as transformative tools in drug discovery, replicating human gut architecture and function.
- Traditional reliance on animal models for toxicity testing leads to high drug attrition rates due to species-specific differences, especially in complex disorders like IBD.
- The FDA's Modernization Act 2.0 and New Approach Methodologies (NAMs) are promoting human-relevant systems, including AI, organoids, and organ-on-chip technologies.
- HIOs enable the study of drug absorption, metabolism, and toxicity in vitro, improving toxicokinetics and pharmacokinetics predictions.
- Patient-derived organoids (PDOs) are being used in clinical trials, bridging preclinical and clinical drug development phases.
- HIOs align with the FDA's NAMs roadmap, enhancing drug safety assessments and reducing animal model dependency.