Regfo
Module 4nonclinicaltoxicologynda● Low priority

4.2.3.4.3 — Carcinogenicity Other

Other studies related to carcinogenic potential

Requirements by Phase

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

Other studies related to carcinogenic potential

Requirements by Phase

IND Phase 3: optional NDA: optional

Content Requirements

  • Other studies related to carcinogenic potential if performed
  • Mechanistic studies supporting weight-of-evidence assessment
  • Studies addressing species-specific tumor findings

Expected Deliverables

  • Study report(s) if performed

ICH Guidelines: S1A, S1B(R1)

Source: ICH S1A

References

ICH S1A

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)

4.2.3.4.2 — Carcinogenicity Short-Term

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

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