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Description
Gerogianni A, Dimitrov JD, Zarantonello A, Poillerat V, Chonat S, Sandholm K, et al

16 If a product is more than minimally manipulated, it does not qualify as an HCTP, and is instead subject to premarket review and approval as a drug or biologic under a biologics license application (BLA)
CYP2E1 expression decreases after a couple days in mouse and human hepatocyte cultures, so studies must be performed on freshly cultured cells

Animal studies first established efficacy comparable to 5% minoxidil, with documented increases in follicle size noted as early as 1993 research
Cell 181 , 10161035.e9 (2020)
