4.2.3.5.4 — Juvenile Animal Studies

Juvenile animal toxicity studies for drugs intended for pediatric use

Requirements by Phase

IND Phase 3: optional NDA: optional

Content Requirements

• Studies in juvenile animals if conducted
• Study design based on pediatric population age and developmental stage
• Endpoints specific to developing organ systems
• Comparison with adult animal findings

Expected Deliverables

• Juvenile animal toxicity study report (if performed)
• Summary comparison with adult toxicity findings

ICH Guidelines: S11

Regulatory Requirements (ICH M3R2)

• Juvenile animal toxicity studies should only be considered when previous animal and human safety data are insufficient to support pediatric studies.
• If a juvenile animal study is warranted, one relevant species (preferably rodent) is generally adequate.
• For long-term clinical trials in pediatric populations where juvenile animal toxicity assessment is recommended, nonclinical studies should be completed before trial initiation.

Regulatory Requirements (ICH S9)

• [Nonclinical] Conduct of studies in juvenile animals should be considered only when human safety data and previous animal studies are considered insufficient for a safety evaluation in the intended pediatric age group.

Note: If pediatric use planned

Source: ICH S11