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Study of PK in feces and urine excretion in rodents and/or non-rodents after single dosing
GLP | No | ||
Test product | TBD | ||
The solvent | TBD | ||
Systematic | Species | SD rat, CD-1 mouse and beagle dog | |
Week age | according to test requirements | ||
Weight | according to test requirements | ||
Quantity | 3/group, male and female half, a total of 6 (according to test requirements) | ||
Test dose | group | Dose | sex/quantity |
Group 1 | TBD | male/3, female/3, | |
Route of administration | TBD | ||
The frequency of administration | Single | ||
Dosage volume | Pre-dose weighing for dosing volume calculation (daily weight recording) | ||
Clinical observation | Symptoms, body weight/day and food intake/day were observed at each collection time point | ||
Blood sample collection time point | Within 24 hours after administration, 4 time periods are collected (can be adjusted according to different requirements) | ||
Analytical method | LC-MS/MS | ||
Data presentation | Drug recovery in feces and urine Concentration of 1 metabolite in the sample at each time (if any) | ||