Module 4nonclinicaltoxicologyndaind● Low priority
4.2.3.7.6 — Impurities
Qualification studies for impurities exceeding ICH Q3A/Q3B thresholds
Requirements by Phase
Phase 1
optional
Phase 2
optional
Phase 3
optional
NDA
optional
Qualification studies for impurities exceeding ICH Q3A/Q3B thresholds
Requirements by Phase
IND Phase 1: optional IND Phase 2: optional IND Phase 3: optional NDA: optional
Content Requirements
- Qualification studies for impurities if performed
- Impurities exceeding ICH Q3A/Q3B thresholds
- Genotoxic impurity assessment (ICH M7)
- Elemental impurities per ICH Q3D
Expected Deliverables
- Impurity qualification study report(s) (if performed)
- Genotoxic impurity assessment report
ICH Guidelines: Q3A(R2), Q3B(R2), M7(R1), Q3D(R2)
Source: ICH Q3A(R2); ICH Q3B(R2)
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
4.2.3.7.5 — Metabolites
Studies on disproportionate human metabolites per MIST guidance
+1 more sections
Check your compliance against this section
Upload your study data and get instant gap analysis with specific regulatory citations.
Try Compliance Check