5.5.3 Carcinogenicity
Carcinogenicity testing under OECD 451 or ICH S1B is conducted over a two-year period in both mouse and rat, using doses up to the maximum tolerated dose,...
PharmacologyPhase 5 — Toxicology Studies (Acute, Sub-Acute, Sub-Chronic, Chronic)5.5 Sub-Chronic and Chronic Toxicity Studies1 min readUpdated 2026-07-13
Carcinogenicity testing under OECD 451 or ICH S1B is conducted over a two-year period in both mouse and rat, using doses up to the maximum tolerated dose, with both gross and microscopic pathological examination and specialised statistical analysis (Fisher's exact test and trend testing) applied to detect tumour incidence differences between treated and control groups.