5.5.1 Sub-Chronic Toxicity (90-Day)

Ninety-day sub-chronic toxicity, governed by OECD 408 for rodent species or OECD 409 for non-rodent species, employs groups of ten males and ten females...

Ninety-day sub-chronic toxicity, governed by OECD 408 for rodent species or OECD 409 for non-rodent species, employs groups of ten males and ten females across three treatment doses plus a vehicle control, with full haematology, biochemistry, urinalysis, organ weight, and complete histopathological examination performed at study termination. The principal outputs of this study are the No Observed Effect Level (NOEL) and No Observed Adverse Effect Level (NOAEL), values that anchor the starting-dose calculation for subsequent chronic studies and, ultimately, for first-in-human clinical trials.