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Safety Pharmacology Core Battery Studies
Effect on the central nervous system
- Irwin method (rat and mouse)
- FOB (cynomolgus monkey and rat)
- Locomotor activity measurement (Equipment: Super Mex)
Test system: rat and mouse
Evaluation parameter: Locomotor activity
Effect on the respiratory system
- Whole body plethysmograph method
Test system: Rat
Evaluation parameters: Respiratory rate, tidal volume, and minute volume
Effect on the cardiovascular system (telemetry)
- Test system: Cynomolgus and rhesus monkeys, and beagle
- Evaluation parameters: Blood pressure (systolic, diastolic, and mean),
- heart rate, and electrocardiography (PR, RR, and QT intervals, QRS time,
and QTc)
Effect on the cardiovascular system (electrophysiology)
- hERG (whole-cell patch-clamp method)
Cells: HEK293 (human embryo kidney), CHO (Chinese hamster ovary)
Evaluation parameters: Potassium tail peak current value
- APD (microelectrode method, whole-cell patch-clamp method)
Cells: Guinea pig papillary muscle and single ventricular myocytes
Evaluation parameters: Action potential duration, resting membrane potential,
action potential amplitude, and maximum rate of rise
- Effect on ionic current
Cell: Guinea pig single ventricular myocytes
Evaluation parameters: Ion current (I Na, I Ca, I Kr)
We are certified with APion in in vitro electrophysiological studies for assessing risks to integrated drug-induced QT prolongation.
Supplemental Safety Pharmacology Studies
Effect on the renal/urinary system
- Urine volume and electrolyte metabolism
Test system: Rat
Evaluation parameters: Urinary volume, urinary concentration and excretion
of electrolytes (Na+, K+, Cl-)
Effect on the digestive system
- Small intestine transport capacity
Test system: Rat and mouse
Evaluation parameter: Transport ratio (%) = Distance traveled by test meal
(cm) / Whole length (cm)×100
- Gastric emptying
Test system: Rat
Evaluation parameter: Phenol red emission (calculated from phenol red in
stomach)
- Gastric secretion
Test system: Rat
Evaluation parameter: Gastric juice volume
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Telemetry room
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Other Safety Pharmacology Studies
Body temperature measurement (telemetry)
- Test system: Cynomolgus and rhesus monkeys, and beagle
- Evaluation parameter: Intra-abdominal body temperature
Diagnostic imaging (computed tomography: CT)
- Test system: Cynomolgus monkey and beagles
- Evaluation parameters: X-ray CT image diagnosis and quantitative analysis
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