4.2.3.7 — Other Toxicity Studies
Other toxicity studies: antigenicity, immunotoxicity, mechanistic, dependence, metabolites, impurities, phototoxicity
Requirements by Phase
Other toxicity studies: antigenicity, immunotoxicity, mechanistic, dependence, metabolites, impurities, phototoxicity
Requirements by Phase
IND Phase 1: required IND Phase 2: required IND Phase 3: required NDA: required
Source: ICH S7A; ICH S7B; ICH S8; ICH S10
Sections
Antigenicity/immunogenicity assessment studies
Immunotoxicity studies evaluating immune function per ICH S8
Mechanistic studies to investigate mode of action for observed toxicities
Abuse liability / dependence studies for CNS-active compounds
Studies on disproportionate human metabolites per MIST guidance
Qualification studies for impurities exceeding ICH Q3A/Q3B thresholds
Related Sections
Up toModule 4: Nonclinical Study ReportsPharmacology studies: primary PD, secondary PD, safety pharmacology, PD drug interactions
Pharmacokinetics studies: analytical methods, ADME, PK drug interactions
Acute toxicity studies in 2 species (rodent and non-rodent) to determine lethal dose and target organ toxicity
Repeat-dose toxicity studies with duration matching or exceeding planned clinical exposure. ICH M3(R2) Table 1 defines minimum durations.
Genotoxicity studies: in vitro (Ames, chromosomal aberration) and in vivo (micronucleus)
+3 more sections
Check your compliance against this section
Upload your study data and get instant gap analysis with specific regulatory citations.
Try Compliance Check