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Single intravenous and low -, medium -, and high-dose oral PK studies in rodents and/or non-rodents
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, total 9 (according to test requirements) | ||
Test dose | group | Dose | sex/quantity |
Po-low dose group | TBD | male /3 | |
Po-high dose group | TBD | male /3 | |
IV | TBD | male /3 | |
The frequency of administration | single | ||
Dosage volume | Weighing before dosage is used to calculate dosage volume | ||
Clinical observation | The symptoms were observed at each blood collection time point | ||
Blood sample collection time | 9 blood collection points in each group within 24 hours, including 0 (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) | ||