If data from multiple animals are used to form a blood concentration-time curve, the number of animals needs to be increased. (2) The design of the sampling time point should take into account the absorption phase, the equilibrium phase (near the peak concentration Cmax) and the elimination phase of the drug. 1. 3. For other drugs administered extravascularly and certain drugs that change the dosage form, absolute bioavailability or relative bioavailability should be provided according to the topic.
Non-clinical ADME research should mainly use humanized materials (such as: human liver microsomes, liver S9, primary hepatocytes, and P450 recombinase, etc.cn/zdyz. Test substance: Relatively stable process, samples with purity and impurity content that # can reflect the quality and safety of samples intended for clinical trials and / or marketed samples. Commonly used animals are mice, rats, rabbits, guinea pigs, dogs, miniature pigs, and monkeys. After administration, determine at least the drug and major metabolites in the heart, liver, spleen, lung, kidney, gastrointestinal tract, gonads, brain, body fat, bone Muscle and other tissue concentrations.
Experimental content 1. 2.do?method= largePage amp; id = 191. It is best to obtain the pharmacokinetic parameters from multiple samples of the same animal. (4) Note that the blood collection route and total blood collection throughout the test period do not affect the animal's normal physiological function and hemodynamics, and generally do not exceed 15% -20% of the total blood volume of the animal.
There are 3 animals of each sex in cryo tubes and 2 ~ 3 animals of each sex in non-rodents. (4) Herbivores such as rabbits should not be used for oral administration. For other drugs, one animal can be selected, and non-rodents are recommended. When performing an animal test as a whole, an intravascular administration test should be performed at the same time to provide absolute bioavailability. The model mice produced by Biosatto are very good. General requirements for experimental design Absorb a new drug for oral administration.