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Hot information：
Top 10 Global CDMO Enterprises| The Meaning of IND, NDA and ANDA| Top 10 Global Clinical Research Organizations in 2021
Mar 10,2021
Pharmacokinetic data management and statistical calculation methods that meet regulatory requirements
In some clinical trials, the results of bioequivalence (BE) and pharmacokinetics (PK) are the main endpoints of the study. Therefore, the data management, statistical calculation process and the compliance, consistency and completeness of the results It will be the focus of review and on-site verification. Recently, the State Food and Drug Administration (CFDA) successively promulgatedRead more
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Pharmacokinetic data management and statistical calculation methods that meet regulatory requirements
Mar 10,2021
Evaluation and thinking on racial differences in pharmacokinetics
Racial /Ethnical sensitivity is an important factor that affects the effectiveness and safety of drugs in different ethnic groups. Among them, pharmacokinetics (PK) is the most important source of drug racial sensitivity. one. According to the definition of racial factors in ICHE5 [1], factors that cause racial differences include internal factors such as genetics andRead more
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Evaluation and thinking on racial differences in pharmacokinetics
Mar 09,2021
Pharmacokinetics and pharmacodynamics
Pharmacology is the science of studying the dosage, mechanism of action and curative effect of drugs. The core of pharmacology is the study of pharmacokinetics and pharmacodynamics. What is pharmacokinetics, pharmacodynamics and pharmacokinetics/pharmacodynamics? Pharmacokinetics studies the concentration of drugs in the body at different time points. On the other hand, pharmacodynamics studies the relationship betweenRead more
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Pharmacokinetics and pharmacodynamics
Mar 08,2021
The impact of antibody targets on ADC pharmacokinetics
Tumor treatment is ushering in the era of ADC drugs. ADC is linked by a powerful cytotoxic payload drug and tumor-targeting antibody by a chemical linker, usually the drug-antibody ratio (DAR) is 3.5-4. The design principle is to directly deliver cytotoxic drugs to the tumor part through antibodies without harming healthy cells. ADC drugs approvedRead more
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Mar 05,2021
The role of pharmacokinetics in the calculation of the initial dose of innovative drugs in the first human trial
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
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The role of pharmacokinetics in the calculation of the initial dose of innovative drugs in the first human trial
Mar 05,2021
Clearance Rate 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 drug inRead more
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Clearance Rate Pharmacokinetics
Mar 04,2021
Application of pharmacokinetic － pharmacodynamic modeling
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
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Application of pharmacokinetic － pharmacodynamic modeling
Mar 03,2021
How to speed up the pre-clinical research process of new drugs
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
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Mar 03,2021
Pre-clinical and initial clinical research phases of preparation research strategies for new drugs
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
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Pre-clinical and initial clinical research phases of preparation research strategies for new drugs
Mar 03,2021
Why are domestically-made innovative drugs always dystocia? Pre-clinical research: a key link that needs to be made up
What happened to the potential targets published in top academic journals? There is a model that has spread all over the world. On October 1, the discovery of PD-1 mechanism won the Nobel Prize in Physiology or Medicine. What is exciting is that it not only found a way to hit tumor cells, but alsoRead more
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