ImmunoTOX A non-animal new approach methodology to test predict human immunotoxicity concerns
Cell type used as testing platform
TRANS-HSC: Characterized Configured Human Hematopoietic type of adult primary and progenitors
Insilico platform used to publish the report
ImmunoTOX software (trained on Convolutional Neural Network)
Assay endpoints:
ImmunoTOX
Immunotoxicity is referred as one of the adverse effects of immune system both local and systemic that result from exposure to compounds/drugs including vaccines. It is evidently demonstrated from clinical data that there is significant morbidity occurred due to immunotoxicity. According to immunotoxicity testing guidance from FDA the five major categories to study immunotoxicity are:
- Hypersensitivity
- Inflammation
- Immunosuppression
- Immunostimulation and auto immunity
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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