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Multiple oral PK studies in rodents (7 or 14 days)
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 males/group, half male and half female, total 18 (according to test requirements) | ||
Test dose | group | Dose | sex/quantity |
Po-low dose group | TBD | male /3, female /3, | |
Po-middle dose group | TBD | male /3, female /3, | |
Po-high dose group | TBD | male /3, female /3, | |
The frequency of administration | More than once | ||
Dosage volume | Pre-dose weighing for dosing volume calculation (daily weight recording) | ||
Clinical observation | The symptoms, weight/day, food intake/day were observed at each blood collection time point | ||
Blood sample collection time | Day1: A total of 9 blood collection points in each group within 24 hours contained 0 points (pre-dose), EDTA-K2 anticoagulation Day7: A total of 9 blood collection points in each group within 24 hours contained 0 points (pre-dose), EDTA-K2 anticoagulation Day14: A total of 9 blood collection points in each group within 24 hours contained 0 points (pre-dose), EDTA-K2 anticoagulation (Can be adjusted according to different requirements) | ||
Analytical method | LC-MS/MS | ||
Data presentation | • LC-MS/MSdetection of plasma concentration of the test substance (ng/mL)• Tmax (h) • t1/2 (h) • F (%) • AUC • MRT Concentration of 1 metabolite in each sample (if any) | ||