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Whether the initial dose of the first human trial is reasonable or not is directly related to the success or failure of the trial. When determining the initial dose, it is necessary to comprehensively consider the existing animal efficacy, toxicity and pharmacokinetic research data, and it is necessary to avoid excessive initial doses. It canRead more

Pharmacokinetics Pharmacokinetics is a branch of pharmacology, which provides a mathematical basis for evaluating the time course of drugs in the body and their effects. Pharmacokinetics can quantify the following processes: drug absorption, distribution, metabolism, and excretion. After the patient takes the drug, these pharmacokinetic processes (commonly called ADME) determine the concentration of the drugRead more

The pharmacokinetic-pharmacodynamics (PK-PD) combined model is an important tool for studying the in vivo process of drugs, the effects of drugs on the body and the relationship between the two, that is, the relationship between dose-concentration and concentration-effect is combined in Research together is more helpful to describe and predict the dose-effect relationship. The useRead more

According to the process of drug research and development, new drug research and development can be divided into two stages: new drug preclinical research and clinical research. The former refers to the sum of all research work before the drug enters the clinical trial, and the latter refers to the research work completed by theRead more

Under the new policy situation, my country’s innovative drugs have sprung up after the rain, but when the preparation process of innovative drugs should be determined and what kind of preparations should be made have always been a big problem for Chinese preparation personnel. In the initial stage of new drug development, the probability ofRead more