Pharmacokinetics (PK) Study, Organ Distribution, In-life and Bioanalysis, Mouse

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BIOLOGICAL INFORMATION
BACKGROUND INFORMATION
This study is to bring early stage pharmacokinetic (PK) and tissue distribution data for evaluating new molecular entities and is 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 18 animals. At designed time points post-test compound administration, the animals are collected for the plasma and organ (defaulted organs as lungs, spleen, heart, brain, livers and kidneys) samples parallelly 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, 60, 120, 240 and 360 minutes after IV or at 10, 30, 60, 120, 240 and 480 minutes after PO.
TURNAROUND TIME
STANDARD
30 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-2 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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