Module 4nonclinicaltoxicologyndaind● Low priority
4.2.3.7.4 — Dependence
Abuse liability / dependence studies for CNS-active compounds
Requirements by Phase
Phase 1
optional
Phase 2
optional
Phase 3
optional
NDA
optional
Abuse liability / dependence studies for CNS-active compounds
Requirements by Phase
IND Phase 1: optional IND Phase 2: optional IND Phase 3: optional NDA: optional
Content Requirements
- Abuse liability and dependence studies if performed
- Physical dependence, self-administration, drug discrimination
- Particularly relevant for CNS-active compounds
Expected Deliverables
- Abuse liability study report (if performed)
- Dependence assessment report (if performed)
ICH Guidelines: M3(R2)
Source: FDA Abuse-Deterrent Opioids 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
4.2.3.7.5 — Metabolites
Studies on disproportionate human metabolites per MIST guidance
4.2.3.7.6 — Impurities
Qualification studies for impurities exceeding ICH Q3A/Q3B thresholds
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