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TOXICOLOGY |
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General toxicity |
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Reproductive and developmental
toxicity |
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Genetic toxicity |
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Carcinogenicity |
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Irritation |
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Immunotoxicity (Antigenicity) |
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Pediatric toxicity |
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Others |
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Other special toxicity
studies, including functional tests, could be
conducted in Ina Research in accordance with
the guidelines for drug application. |
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Phototoxicity studies |
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Ocular toxicity studies |
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Renal toxicity studies |
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Evaluation of environmental
risk by exogenous endocrine disruptors |
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SAFETY PHARMACOLOGY |
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Battery Studies |
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Central nervous
system |
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Functional observation
battery (FOB) - rats |
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Modified Irwin's -
mice |
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Gross behavioral observation
- monkeys |
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Cardiovascular system |
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ECG, heart rate, blood
pressure are determined by telemetry system
in conscious monkeys and dogs |
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ECG, heart
rate, blood pressure, left ventricular pressure
and blood flow are determined in anesthetized
monkeys and dogs |
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Guinea pig
APD |
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Respiratory system |
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Blood gases
or StO2
in conscious monkeys and dogs |
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Respiratory
rate, tidal volume in conscious rats |
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| Follow-up and Supplemental Studies |
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Central nervous
system |
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Behavioral observation
- mice, rats, monkeys |
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Spontaneous locomotor
activity - mice, rats |
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Synergistic or antagonistic
effects on convulsions - mice, rats |
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Motor coordination
- mice, rats |
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Analgesic action -
mice, rats |
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Normal body temperature
- mice, rats |
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Observation for catalepsy
- rhesus monkeys |
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Aversion test - rhesus
monkeys |
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Respiratory and
cardiovascular systems - dogs, monkeys, rats,
guinea pigs |
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Respiratory rate,
ECG, heart rate, blood pressure, blood gases,
StO2 are
determined in conscious monkeys and dogs |
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Respiratory rate,
ECG, heart rate, blood pressure, left ventricular
pressure, blood flow are determined in anesthetized
monkeys and dogs |
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Blood pressure and
heart rate are determined in conscious rats
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Guinea pig APD |
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Isolated guinea pig
atrium |
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Respiratory rate and
tidal volume in conscious rats |
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Gastro-intestinal
system - mice, rats |
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Transit time |
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Gastro-intestinal
injury potential |
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Gastric secretion |
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Bile secretion |
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Vomiting |
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Autonomic nervous
system - guinea pigs, rats |
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Effects are assessed
in isolated organs |
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Skeletal
muscle - mice, rats |
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Effects of the muscle
relaxation potential are assessed in rats and
mice |
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Effects on the neuromuscular
junction are assessed in rats |
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Renal/Urinary system - rats, dogs, monkeys |
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Effects on water and
electrolyte metabolism are assessed |
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Blood
coagulation and hemolysis |
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DRUG DEPENDENCY |
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Physical dependence
development studies and cross-physical dependence
studies in monkeys and rats |
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Self-administration
studies (intravenous or intragastric) for evaluation
of psychological dependence potential in monkeys |
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Drug discrimination
study in monkeys |
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DRUG EFFICACY |
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Central nervous
system |
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Parkinsonism - cynomolgus monkeys |
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Parkinsonism induced
by MPTP |
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Analgesic tests - rats,
mice, rhesus monkeys |
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Analgesic effects
are determined by the tail base-pressure (mice),
tail flick (rats), tail withdrawal (rhesus monkeys),
Randall-Selitto (rats) or acetic acid-writhing
(mice) methods. |
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Pruritus/Skin scratching
test - rhesus monkeys |
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Morphine-induced skin
scratching-inhibitory effects of drugs |
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Neuropathic
pain - cynomolgus monkeys |
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Neuropathic pain induced
by ligation of 7th spinal nerve |
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Anxiety/Anti-conflict test - rhesus monkeys |
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Conflict behavior
induced by electric shock and feeding |
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Aversion
test - rhesus monkeys |
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Observations
for catalepsy - rhesus monkeys |
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Circulatory system |
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Measurements of blood
pressure, electrocardiogram, heart rate, blood
flow and left ventricular pressure in anesthetized
animals - dogs, monkeys |
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Measurements of blood
pressure and electrocardiogram in conscious
animals - dogs, monkeys (telemetry, holter ECG) |
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Anti-hypertensive
effects in SHR rats |
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Osteological tests |
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Osteoporosis model (OVX - rats,
monkeys; Glucocorticoid-induced - monkeys) |
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Denervation of sciatic
nerve - rats |
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Bone defect model
(femur - rats; skull - dogs) |
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Tail-suspension model
- rats |
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Measurement of bone
mineral (by DXA), mechanical strength and histomorphometry
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Ophthalmology |
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Uveitis
model - rabbits |
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Uveitis induced by
LPS |
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Intraocular
pressure |
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In conscious monkeys
and rabbits |
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Lipids |
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Effects
of blood lipid levels in WHHL rabbits |
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Hypercholesterolemia model - monkeys |
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Hypercholesterolemia
induced by lipid emulsion or special diet |
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Renal failure |
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Puromycin
aminonucleoside nephrosis - rats |
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Nephrectomized
model- rats |
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Three fourths (3/4)
or 7/8 nephrectomy |
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Thy-1 nephrosis
model- rats |
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Nephrosis induced
by anti-thymocyte serum (ATS) |
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Serum sickness
type nephritis - rats |
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Induced by ovalbumin |
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Masugi nephritis
- rats |
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K-35-induced
nephritis model - rats and monkeys |
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Type IV Collagen-induced
nephritis |
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Renal failure
in Streptozotocin-induced diabetes - rats |
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Anti-inflammation |
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Collagen-induced arthritis
- rats, mice |
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Carrageenin-induced
edema - rats |
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Total Parenteral
Nutrition (TPN) |
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Nutritional
effects of TPN - dogs, monkeys |
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Continuous infusion
(24-hr IVH) for up to 3 months. |
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Evaluation
of TPN efficacy on burn model - rats |
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Post-operative
care with TPN for partial intestinectomy model
- dogs |
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Others |
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Gastric
acid secretion - monkeys |
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Gastrin- or histamine-induced
secretion of gastric acid |
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Gastric
fluid secretion - rats |
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Pylorus ligation |
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Diabetic
model |
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ZDF rats, NOD mice,
KKA /Ta mice |
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Measurement
of blood gases and tidal volume - dogs, monkeys |
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Wound healing
test in traumatic back skin defect models -
diabetic mice |
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Suppressive
effects on uterine and vaginal atrophy in ovariectomized
rats |
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Hemorrhagic
shock model - rabbits, dogs |
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Measurement
of cutaneous temperature - rabbits |
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