If you are interested in what is going on in the whole New Alternative Methodologies (NAM) space at the Agency, here is an example.
From the announcement, its a " an organ-on-a-chip technology, a type of micro-physiological system (MPS), to study drug-induced liver injury (DILI) for certain drug candidates.
This accepted LOI is for a human Liver-Chip drug development tool (DDT) used to assess the risk of DILI in adults to create relevant data for a drug's investigational new drug (IND) submission. The Liver-Chip model works by growing four human liver cell types in a micro-engineered environment that recreates the natural physiology and mechanical forces that cells experience within the human body. This allows real time monitoring of signs of drug induced damages compared to control conditions."
More information is available here:
https://www.fda.gov/drugs/drug-safety-and-availability/fdas-istand-pilot-program-accepts-submission-first-organ-chip-technology-designed-predict-human-drug
#fda #NAM #DILI #OrganOnAChip
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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