Module 4nonclinicaltoxicologynda● Low priority
4.2.3.7.5 — Metabolites
Studies on disproportionate human metabolites per MIST guidance
Requirements by Phase
Phase 1
N/A
Phase 2
optional
Phase 3
optional
NDA
optional
Studies on disproportionate human metabolites per MIST guidance
Requirements by Phase
IND Phase 2: optional IND Phase 3: optional NDA: optional
Content Requirements
- Studies on disproportionate human metabolites if performed
- MIST (Metabolites in Safety Testing) evaluation
- Qualification of metabolites exceeding exposure thresholds
- Nonclinical safety assessment of major human metabolites
Expected Deliverables
- Metabolite safety study report(s) (if performed)
- MIST assessment summary
ICH Guidelines: M3(R2)
Source: ICH M3(R2) Note 3; FDA MIST Guidance
References
Related Sections
Up to4.2.3.7 — Other Toxicity Studies4.2.3.7.1 — Antigenicity
Antigenicity/immunogenicity assessment studies
4.2.3.7.2 — Immunotoxicity
Immunotoxicity studies evaluating immune function per ICH S8
4.2.3.7.3 — Mechanistic Studies
Mechanistic studies to investigate mode of action for observed toxicities
4.2.3.7.4 — Dependence
Abuse liability / dependence studies for CNS-active compounds
4.2.3.7.6 — Impurities
Qualification studies for impurities exceeding ICH Q3A/Q3B thresholds
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