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Sponsor

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  1. FDA Electronic Document Room Biostat Reviewer Doses, Survival Tumor incidence • Carcinogenicity study • Study report – pdf (SEND?) • Tumor data – xpt (SEND?) • 13 week toxicity study • Study report – pdf (SEND?) • Human PK study • Study report – pdf (SDTM?) Sponsor Pharm/Tox Reviewer Tumor incidence with statistical significance Doses, Survival AUCs (animal and human) Result – labeling statement “The NOAEL for tumors in mice was 30 mg/kg or 15 times the exposure in humans at the maximum recommended human dose.” Clin Pharm Reviewer Human Drug Conc.

  2. NOAEL FDA Biostat-generated table

  3. AUC at NOAEL TK parameters from tox study report PK parameter from Clin Pharm Review Human AUC at maximum recommended human dose = 4150 ng∙h/mL Animal to human AUC ratio at NOAEL = 61500 ng∙h/mL  4150 ng∙h/mL= 14.82 ≈ 15