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In Vitro Study for Protein Binding

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Equilibrium dialysis/ultrafiltration was used to evaluate the binding rate of a test product to human and animal plasma/other histamins to accurately evaluate the free test concentration and provide parameters for the safety and efficacy of the drug.


Incubation system

Plasma

Species

CD1 Mouse, SD Rat, Beagle, Crab-eating Monkey, Miniature Pig, New Zealand Rabbit, Human (other species or strains available upon request)

Test concentration

 3 concentrations, which were designed according to the drug efficacy concentration

Incubation system protein concentration

To Be Determined (available on request)

Incubation time

Balance dialysis method: 4-6 hours (or available on request)

Ultrafiltration: 10-30 minutes (or available on request)

Overspeed centrifugation: incubation at 37for 30 minutes 230000g centrifugation for 4-6 hours (or available according to different requirements)

Analytical method

LC-MS/MS

Data presentation

Equilibrium dialysis method:

Protein binding rate

recovery

stability

Ultrafiltration method:

Nonspecific binding (NSB)

Protein binding rate

recovery

Stability or other parameters

Ultrafast centrifugal method:

Protein binding rate


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