HepatoSIGHT:A non-animal new approach methodology to test predict human hepatotoxicity like safety concerns
- Mitochondrial functional impairment – Copy number, mitochondrial membrane potential
- Initiation of apoptosis/Necrosis – Staining with annexin5/RT PCR analysis
- Alteration of protein function – enzymes or transporters
- Alterations of redox status – SOD status
- Activation of immune or inflammatory response – These factors can be measured for IL-2, IL-31, IL-17A etc
Reference:
Avila AM, Bebenek I, Bonzo JA, Bourcier T, Davis Bruno KL, Carlson DB, Dubinion J, Elayan I, Harrouk W, Lee SL, Mendrick DL, Merrill JC, Peretz J, Place E, Saulnier M, Wange RL, Yao J, Zhao D, Brown PC. An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs). Regul Toxicol Pharmacol. 2020 Jul;114:104662. doi: 10.1016/j.yrtph.2020.104662. Epub 2020 Apr 20. PMID: 32325112.
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