5.5 Sub-Chronic and Chronic Toxicity Studies
5.5 Sub-Chronic and Chronic Toxicity Studies contains 4 topic pages in Phase 5 — Toxicology Studies (Acute, Sub-Acute, Sub-Chronic, Chronic).
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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...
5.5.2 Chronic Toxicity (12 Months or Longer)
For drugs intended for use in humans for longer than six months, chronic toxicity testing under OECD 452 (rodent) or OECD 453 (combined chronic...
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,...
5.5.4 Reproductive and Developmental Toxicity
Segment I reproductive toxicity testing (OECD 415, ICH S5(R3)) evaluates fertility and early embryonic development in both male and female animals through...