In Vitro ADME, Stability Test, Plasma, Human
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OVERVIEW
DOCUMENTS/REFERENCES
BIOLOGICAL INFORMATION
BACKGROUND INFORMATION
Plasma stability is important for drug development. Unstable tests with a rapid metabolism rate may lower the exposure time at the therapeutic target. The in vitro stability test can provide an in vitro platform to test the plasma stability for the test articles from human plasma matrix.
ORGANISM
Human
ASSAY INFORMATION
ASSAY TYPE
Biochemical
TESTING INFORMATION
PROCEDURE SUMMARY
Human plasma matrix is used for in vitro plasma stability test. The test article is dissolved in DMSO at a concentration of 0.5 ng/μL. A 10 μL of stock solution is added to 100 μL of plasma matrices (compound-plasma mixture) in the wells of the 96-well plate. The plate is incubated at 37°C for 5, 15, 30, 60, or 120 minutes. Then, the compound-plasma mixture is deproteinized with 300 μL of acetonitrile containing an internal standard. The mixture is then centrifuged at 4000 rpm, 21°C for 5 minutes to precipitate the protein. The supernatant is collected to measure the concentration of the test article with LC-MS/MS. The procedure can be customized based on client’s request.
TURNAROUND TIME
STANDARD
20 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, 2013). The study protocol is 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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