Evaluation of in vitro Inhibitory Effect on CYP450 Enzymes Activity in Freshly IsolatedHepatocytes.docVIP

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Evaluation of in vitro Inhibitory Effect on CYP450 Enzymes Activity in Freshly IsolatedHepatocytes.doc

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EvaluationofinvitroInhibitoryEffectonCYP450EnzymesActivityinFreshlyIsolatedHepatocytesEvaluationofinvitroInhibitoryEffectonCYP450EnzymesActivityinFreshlyIsolatedHepatocytes

Evaluation of in vitro Inhibitory Effect on CYP450 Enzymes Activity in Freshly Isolated Rat Primary Hepatocytes Sponsor Study Monitor Study Director Testing Facility Study Identification Medicilon/MPT Study Number Medicilon/MPT Protocol Number Protocol Issue Date Sponsor Approval Date Page Number OBJECTIVE This assay is designed to evaluate the ability of test articles to inhibit CYP450 1A2, CYP450 2C9, CYP450 2C19, CYP450 2D6, CYP450 3A4 following incubation with freshly isolated rat primary hepatocytes. The results will be served as bedrocks for further investigation on drug-drug interaction and hepatotoxicity. REGULATION COMPLIANCE This study will be conducted in accordance with Medicilon/MPI Inc Standard Operating Procedures (SOPs). All procedures in the protocol are in compliance with the animal protocol approved by Medicilon/MPI Inc Animal Center. This study will not be considered within the scope of the Good Laboratory Practice regulations. TEST ARTICLE The Sponsor will provide the test articles. The Sponsor will be responsible for the identity, purity, and stability of each test article. Specific information follows. Test articles: Lot No.: Storage conditions: Test Article disposition and safety precautions Any remaining test article will be stored at -20oC in Medicilon/MPI Inc and return to the Sponsor or at a facility designated by the Sponsor. Personnel will follow all safety precautions as required by test facility policies and procedures. ANIMAL HUSBANDARY Animals Species: rat Strain and source: Sprague-Dawley Age at Delivery to the Facility: 6~7 weeks /130~150 g Age at Isolation of hepatocytes: 180~200g Number and Sex: 1~2, Male Source: Shanghai SLAC experimental animals company Housing and Enrichment The animals are maintained and monitored for good health in accordance with test facility SOPs and at the discretion of the laboratory animal veterinarian. Food and water Upon arrival at the facility, the rats will be plac