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Study of PK in rodent tissue distribution after single administration
GLP | No | ||
Test product | TBD | ||
The solvent | TBD | ||
Systematic | Species | SD rat, CD-1 mouse | |
Week age | according to test requirements | ||
Weight | according to test requirements | ||
Quantity | 6/timepoint, male and female half, a total of 24 (according to test requirements) | ||
Test dose | group | Dose | sex/quantity |
Group 1 | TBD | male/12, female/12, | |
Route of administration | IV | ||
The frequency of administration | Single | ||
Dosage volume | Pre-dose weighing for dosing volume calculation (daily weight recording) | ||
Clinical observation | Symptoms were observed at each collection time point | ||
Blood/tissue sample collection time point | 0.25, 2, 8, 24 hours terminal blood collection (can be adjusted according to different requirements) | ||
Tissue collection | Male: heart, liver, kidney, lung, spleen, stomach, intestine, brain, muscle, testicles, bladder, prostate Female: heart, liver, kidney, lung, spleen, stomach, intestine, brain, muscle, uterus, bladder, ovary | ||
Analytical method | LC-MS/MS | ||
Data presentation | Mother drug concentration in different tissues at different time points | ||