Pharmacokinetics (PK) Study, Plasma, In-life and Bioanalysis, Hamster
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BIOLOGICAL INFORMATION
BACKGROUND INFORMATION
This study is to bring early stage pharmacokinetic (PK) data for evaluating new molecular entity and is prerequisite for interpreting preclinical efficacy and toxicology results.
ORGANISM
Hamster
ASSAY INFORMATION
ASSAY TYPE
In Vivo
DETECTION METHOD
LC-MS/MS
MEASURED RESPONSE
Exposure level
TESTING INFORMATION
PROCEDURE SUMMARY
Test compound is administered intravenously (IV, 1 mg/kg) or orally (PO, 10 mg/kg) to groups of 3 animals. At designed time points post test compound administration, the plasma samples are obtained via the cannulas and stored at -70°C until extraction and analysis using the LC-MS/MS method. Suggested Testing: n=3/time point. A dose of 1 mg/kg for IV and 10 mg/kg for PO Dosing volume at 5 mL/kg for IV and 10 mL/kg for PO Sampling time points: 3, 10, 30, 60, 120, 240, 360 and 1,440 minutes post IV dosing or 10, 30, 60, 120, 240, 360, 480 and 1,440 minutes post PO dosing.
TEST CONCENTRATION / DOSE
Suggested dose is i.v. (2 mg/kg) or p.o. (10 mg/kg)
TURNAROUND TIME
STANDARD
30 Days
CLINICAL RELEVANCE
THERAPEUTIC AREA
Other
ADDITIONAL INFORMATION
BRAND
PDS
TESTING LOCATION
Taiwan - Taipei
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