BUSINESSSafety Pharmacology

Test Introduction

Since ICH has established guidelines (ICH S7A) In regards to safety pharmacology, the guidelines for safety in pharmacology (ICH S7B) and clinical examination(E14)was adopted in May 2005 in order to evaluate the proarrythmic potential (QT interval prolon- gatlon) which has gained its recognition as a possible source of problem that causes sudden death from tachyarrhythmia. Therefore, the importance on the safety issue in pharmacology has gaining its attention.

As Biotoxtech Inc. received the first official recognition by GLP among Korean corporation in October 2008. Biotoxtech Inc. is providing officially recognized services in the field of pharmacology. The research on pharmacology, which is to evaluate side effects on the central nervous system, respiratory system and cardiovascular systems, exhibits a professional per-formance in regards to Core battery. The research in the field of safety pharmacology Con-sidering specialty developmental levels and test materials, a profes-

Trusted Research Evaluations(Applicable to OECD, JMHW, MFDS)

Central nervous system
  • Evaluates the effect on central nervous system of rats according to the method of FOB
  • Evaluates the effect on central nervous system of mice according to the method of Irwin test
Cardiovascular system
  • Evaluates the effect on cardiovascular system of beagle dogs under unanesthetized and unrestrained conditions using telemetry system (in vivo)
  • Evaluates the effect on hERG Channel Currents Expressed in Stably Transfected HEK-293 Cells (in vitro)
Respiratory system
  • Evaluates the effect on respiratory system of rats using whole body plethysmography
Follow-up studies
  • Central Nervous System : barbiturate-induced sleep test, proconvulsive test, nociception : pain sensitivity
  • Cardiovascular System : cardiac output, ventricular contractility, vascular resistance
  • Respiratory System : pulmonary arterial pressure, blood gases, blood pH
Supplemental studies
  • Renal/Urinary System : urinary volume, specific gravity, osmolality, pH, fluid/electrolyte balance, proteins, etc.
  • Autonomic Nervous System : test on smooth muscles of bronchus and uterus
  • Gastrointestinal System : gastric secretion, gastric pH measurement and pooling, total acidity, transit time in vivo, ileal contraction in vitro