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