4.2.3.4 — Carcinogenicity
Carcinogenicity studies: long-term bioassay, short-term transgenic models, other studies
Requirements by Phase
Carcinogenicity studies: long-term bioassay, short-term transgenic models, other studies
Requirements by Phase
IND Phase 1: optional IND Phase 2: optional IND Phase 3: required NDA: required
Source: ICH S1A; ICH S1B
Sections
2-year carcinogenicity bioassay in rodents. Required if drug intended for chronic use (≥6 months)
Short/medium-term carcinogenicity study using transgenic models (e.g., rasH2, p53+/−)
Other studies related to carcinogenic potential
Related Sections
Up toModule 4: Nonclinical Study ReportsPharmacology studies: primary PD, secondary PD, safety pharmacology, PD drug interactions
Pharmacokinetics studies: analytical methods, ADME, PK drug interactions
Acute toxicity studies in 2 species (rodent and non-rodent) to determine lethal dose and target organ toxicity
Repeat-dose toxicity studies with duration matching or exceeding planned clinical exposure. ICH M3(R2) Table 1 defines minimum durations.
Genotoxicity studies: in vitro (Ames, chromosomal aberration) and in vivo (micronucleus)
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