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What are the Procedures for DMPK?

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The DMPK study of the new drug in the corresponding patient, including the pharmacokinetic study of a single dose or/and multiple doses;

If the new drug is a prodrug or a drug that is mainly eliminated in the human body by metabolism, the metabolic pathway, metabolic structure and pharmacokinetics of the new drug need to be studied.

According to the characteristics of new drug management, the needs of clinical medication and the feasibility of experimental conditions, the investigator can selectively conduct:
1) Pharmacokinetic research in the interaction between new drugs and other drugs;
2) Research on special pharmacokinetics of new drugs (including the effects of liver and kidney function impairment, the elderly and other factors on pharmacokinetics);
3) Pharmacokinetic studies of different races;
4) Research on the correlation between blood drug concentration in human body and clinical pharmacological effects, etc.

The clinical pharmacokinetics research content of biological agents is basically the same as above.

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