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Safety Pharmacology Your Position:Home - CRO - Safety Pharmacology

According to ICH guidelines, safety pharmacology studies of an investigational drug may be required prior to human Phase I study. The assessment of the drug on major physiological functions of central nervous, cardiovascular and respiratory systems should be performed with GLP compliance.

 

Chemistry and Formulation Services

• Lead optimization

• Drug process development

• Contract synthesis of kilo-gram scale drug intermediates

• Synthesis of drug candidates with GMP compliance

 

Formulation for Preclinical and Clinical Trial Material

• Tablets-immediate/control release, enteric coded

• Pellets-- immediate/control release, enteric coded

• Liquids—suspension, solution

• Parenterals, IV

• Inhalations—metered dose inhaler, dry powder

• Nasal sprays

Service categories

      Central Nervous System
      Functional Observational Battery
      EEG, CT scan, MRI, PET scan
      Cardiovascular System
      Telemetry in freely moving animals (blood pressure, heart rate, body temperature)
      Restrained/anesthetized animal models (blood pressure, heart rate,electrocardiogram)
      Respiratory System 
      Restrained animals (tidal and minute volumes, respiratory rate, blood gasses)
      Restrained/anesthetized animal models (blood pressure, heart rate,electrocardiogram)
      Cardiac Repolarization Assessment- measurement of QT intervals and other ECG Parameters in conscious or anesthetized animals

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