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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 |