Table 2
Clinical pathology and histology parameters.
| Preliminary margin-of-safety topical (Study #1) | Regulatory margin-of-safety topical (Study #2) | Regulatory oral tolerance (Study #3) | |
|---|---|---|---|
| Hematology | |||
| RBC (red blood cell count) | √ | √ | √ |
| WBC (white blood cell count, absolute and differential) | √ | √ | √ |
| HGB (hemoglobin concentration) | √ | √ | √ |
| HCT (hematocrit) | √ | √ | √ |
| Platelet count | √ | √ | √ |
| MCV (mean corpuscular volume) | √ | √ | √ |
| MCH (mean corpuscular hemoglobin) | √ | √ | √ |
| MCHC (mean corpuscular hemoglobin concentration) | √ | √ | √ |
| Reticulocytes (% and absolute) | √ | ||
| LUC (large unstained cell) | √ | ||
| RDW (red cell distribution width) | √ | ||
| Platelet estimate | √ | ||
| RBC morphology | √ | ||
| Serum biochemistry | |||
| Total Protein | √ | √ | √ |
| Albumin | √ | √ | √ |
| Globulin (calculated) | √ | √ | √ |
| Total bilirubin | √ | √ | √ |
| Blood urea nitrogen | √ | √ | √ |
| Creatinine | √ | √ | √ |
| ALT (alanine aminotransferase) | √ | √ | √ |
| ALP (alkaline phosphatase | √ | √ | √ |
| AST (aspartate aminotransferase) | √ | √ | √ |
| GGT (gamma glutamyl transferase) | √ | √ | |
| Glucose | √ | √ | √ |
| Total cholesterol | √ | √ | √ |
| Calcium | √ | √ | √ |
| Chloride | √ | √ | √ |
| Phosphorus | √ | √ | √ |
| Potassium | √ | √ | √ |
| Sodium | √ | √ | √ |
| Triglycerides | √ | √ | √ |
| Magnesium | √ | ||
| Appearance (e.g. degree of hemolysis, lipemia, icterus) | √ | ||
| Coagulation factors | |||
| PT (prothrombin time) | √ | √ | |
| Fibrinogen | √ | √ | |
| APTT (activated partial thromboplastin time) | √ | √ | |
| Urinalysis | |||
| SG (specific gravity) | √ | √ | √ |
| pH | √ | √ | √ |
| URO (urobilinogen) | √ | √ | √ |
| COL (color) | √ | √ | |
| CLA (clarity) | √ | √ | |
| PRO (protein) | √ | √ | √ |
| GLU (glucose) | √ | √ | √ |
| KET (ketones) | √ | √ | √ |
| BIL (bilirubin) | √ | √ | √ |
| Nitrite | √ | ||
| BLD (occult blood) | √ | √ | |
| Microscopy of sediments (crystals, RBC, WBC, epithelial cells) | √ | √ | √ |
| Histology | |||
| Gross lesions (when applicable) | √ | √ | |
| Heart | √ | √ | |
| Kidneys (2) | √ | √ | |
| Liver (sections of two lobes) | √ | √ | |
| Spleen | √ | √ | |
| Thymus | √ | √ | |
| Lungs (including bronchi) | √ | √ | |
| Skin from application site | √ | √ | |
| Skin from abdomen | √ | ||
| Skin with mammary gland | √ | ||
| Adrenals (2), aorta, bone with marrow, femur, sternum, bone marrow smear, brain, cervix, eyes with optic nerves (2), gallbladder, esophagus, stomach, duodenum, jejunum, ileum, cecum, colon, rectum, lymph nodes (mandibular, mesenteric, prescapular (2)), ovaries with oviducts (2), pancreas, sciatic nerve, peyer’s patches, pituitary, prostate, mandibular salivary gland (2), skeletal muscle (femur rectoris), spinal cord (cervical, thoracic, lumbar), testes with epididymis (2), thyroids with parathyroids (2), tongue, trachea, ureters, urinary bladder, uterus, vagina | √ | ||
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