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Dose escalation tolerability
- 1. Dose Escalation / Tolerability Study Design
• Dose route: Oral, IV bolus, subcutaneous, intraperitoneal, intramuscular, dermal, topical
• Dose used: Initiate starting dose based on in vitro cytotoxicity and/or published literature. If MTD is not determined
industry standard dose escalation with increments for rapid (1.8x) or slow (1.15x) escalations are used.
• Clinical Chemistry Panel: Albumin, Alkaline Phosphatase, Bilirubin/Total, BUN, Calcium, Chloride, Cholesterol,
Protein/Total, Creatinine, Sodium, ALT, AST, Phosphorus, Potassium, Glucose, GGT, Uric Acid, Triglycerides
• Hematology Parameters: Automated WBC, RBC, Hgb, Hct, Platelet Count, MPV, MCV, MCH, MCHC, and WBC
• Gross Necropsy: To examine the organs for potential abnormalities and lesions
• Histology / Immunohistochemistry: H&E and other specialized staining