Module 4
4.2.3.7.7 — Other (Phototoxicity, Safety Pharmacology)
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
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