Regfo
Module 4nonclinicaltoxicologynda● High priority

4.2.3.4.2 — Carcinogenicity Short-Term

Short/medium-term carcinogenicity study using transgenic models (e.g., rasH2, p53+/−)

Requirements by Phase

Phase 1
N/A
Phase 2
N/A
Phase 3
required
NDA
required

Short/medium-term carcinogenicity study using transgenic models (e.g., rasH2, p53+/−)

Requirements by Phase

IND Phase 3: required NDA: required

Content Requirements

  • Short/medium-term carcinogenicity studies using transgenic models
  • Models: rasH2, p53+/-, Tg.AC, or other validated models
  • Study design rationale and high-dose selection
  • GLP required

Expected Deliverables

  • Transgenic model carcinogenicity study report (GLP)
  • Dose selection rationale

ICH Guidelines: S1A, S1B(R1)

Source: ICH S1A; ICH S1B

References

ICH S1AICH S1B

Related Sections

Up to4.2.3.4 — Carcinogenicity
4.2.3.4.1 — Carcinogenicity Long-Term

2-year carcinogenicity bioassay in rodents. Required if drug intended for chronic use (≥6 months)

4.2.3.4.3 — Carcinogenicity Other

Other studies related to carcinogenic potential

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