Pharmacokinetics (PK) Study, Serial Microsampling, Plasma, In-life and Bioanalysis, Mouse
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BIOLOGICAL INFORMATION
BACKGROUND INFORMATION
This study is to bring early stage pharmacokinetic (PK) data for evaluating new molecular entities (NMEs) and is a prerequisite for interpreting preclinical efficacy and toxicology results.
ORGANISM
Mouse
ASSAY INFORMATION
ASSAY TYPE
In Vivo
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 animals are collected for the plasma samples serially and stored at -70°C until extraction and analysis using the LC-MS/MS method. Suggested Testing: n=3/time point (parallel or semi-serial sampling). A dose of 2 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.
TURNAROUND TIME
STANDARD
15 Days
CLINICAL RELEVANCE
THERAPEUTIC AREA
Other
ADDITIONAL INFORMATION
BRAND
PDS
TESTING LOCATION
Taiwan - Taipei
OTHER INFORMATION
We will readily accommodate client-specified alterations. These studies are performed at our AAALAC accredited BSL-1 laboratory in Taipei, Taiwan. All aspects of this work are performed in general accordance with the Guide for the Care and Use of laboratory animals (National Academy Press, Washington, DC, 2011). The study protocol was approved by the Pharmacology Discovery Services IACUC and is performed with the oversight of veterinarians to assure the humane treatment of laboratory animals.
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