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NIH Clinical Pharmacology 3-25-10Other Toxicology Studies(S9 Guidance)• Genotoxicity– Not essential for oncology clinical trials– Should be performed to support marketing application• Carcinogenicity– Not warranted for marketing in oncology patients• Immunotoxicity– May evaluate in general toxicology studies for oncology– May require more extensive study for knownimmunomodulators• Photosafety testing– Initial phototoxic potential assessment prior to Phase 1based upon known photochemical properties-- S9 Guidance for Industry, 201037