Medicilon Logo
|
search icon search icon language icon contact icon menu icon
Medicilon Logo
|
search icon close search icon language icon contact icon menu icon
CN
Message
Contact Us
Close Button
Back To Top
Online Message×
Click switch
Close Button
FAQs

What is in vivo PK Study?

BA method development + PK pre-experiment + BA method validation

Determine a reasonable calibration range, examine the interference and stability in the actual sample, and optimize the blood sampling time point (3 points near tmax at least; time points in the absorption phase, ast3 *t/2 or Clast 1/10 Cmax)

Routine PK experiment:

Rodent + non-rodent, lowest effective dose + medium dose + high dose, fasting before and after oral administration. For other extravascular administration routes, on-rodent IV/EV cross-over should be done. An effective dose was selected for repeated administration, and the C-t curve and PK parameters of the first and last administration after reaching steady state were compared.

Tissue distribution experiment:

Rodent, after selecting an effective dose for administration, at least one time point was taken at the plasma absorption phase, near Cmax, and elimination phase to take heart, liver, spleen, lung, kidney, gastrointestinal tract, gonad, brain, body fat, bone and muscle and target tissues, the concentrations of drugs and major metabolites were measured in boat muscle and target tissues.

Excretion test (substance balance)

Rodent, after selecting an effective dose for administration, collected urine in sections until the concentration of drugs and major metabolites in the samples collected during the time period was lower than LLOQ or less than 1% of Dose. Another group of bile ducts were administered after intubation, and bile was collected in sections. Generally, radioisotope labeling should be used. It can be arranged in the clinical phase.