Test Area
Safety pharmacology evaluation
- Safety pharmacology studies investigate potential undesirable pharmacodynamic effects of a test article on physiological function in relation to exposure in the therapeutic range and above.
- The data of safety pharmacology studies are among the data that must be submitted for review for FDA Investigation New Drug (IND) application.
- International regulations for safety pharmacology studies include ICH S7A and ICH S7B which introduce an overview of safety pharmacology studies and provide a rough test method for the core battery tests that must be performed during safety pharmacology studies.
Services
- General pharmacology
- Safety pharmacology
Study types
- General behavior test
- CNS study
- PNS study
- Respiratory study
- Cardiovascular study
- Gastro-intestinal study
Safety PharmacologyCore Battery
- Body Temperature & General Behavior Assessment
Comprehensive evaluation of body temperature changes and behavioral responses using Irwin
and Functional Observation Battery(FOB) tests.
- Respiratory Functions Assessment
Measurement of respiratory rate and volume in rodents (rats and mice) to assess respiratory
safety.
- Telemetry Monitoring in Beagle Dogs
Continuous real-time monitoring of cardiovascular and physiological parameters including heart
rate and body temperature.
- Ion Channel Profiling
Targeting key cardiac ion channels (Kv 11.1/hERG, Nav 1.5, Cav 1.2) vai manual patch clamp
electrophysiology to assess proarrhythmic risk.
- Multi-Electrode Array(MEA) Assay Using hiPSC-Derived Cardiomyocytes
High-throughput evaluation of electrophysiological activity in human induced pluripotent stem
cell-derived cardiomyocytes.
Follow-up study
- Multi Ion Channel Assay & In Silico Modeling
Computational prediction of ion channel interactions and cardiac saftety liabilities.
- Langendorff Heart Isolation Multi Ion Channel Asssay
- Spontaneous Locomotor Activity Testing
Assessment of drug effects on natural movement and activity levels.
- Sleep Duration Evaluation
Measurement of sedative or stimulatory effects on sleep patterns.
- Motor Coordination Testing
Evaluation of balance and coordination to detect neurotoxic effects.
- Seizure Models
Electroshock and Pentylenetetrazole (PTZ)-induced seizure tests for anticonvulsant
and proconvulsant screening.
- Pain and Analgesia Testing
Acetic acid-induced writhing and hot-plate licking tests for evaluation of nociceptive responses.
- Autonomic Nervous System Evaluation
Assessment of sympathetic and parasympathetic nervous system acivity.
- Smooth Muscle Contractility Assays
Measurement of contraction and relaxation in guinea pig smooth muscle preparations.
- Gastrointestinal and Cardiovascular Safety Assessments
Evaluation of drug effects on GI motility, cardiac function, and gastrointestinal transit.
- Renal Function Testing
Analysis of urine output and electrolyte excretion to assess renal effects.
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Corestemchemon Inc