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The size of the particles is called particle size. The particle size of the API is closely related to the homogeneity of the preparation process in terms of mixing, the accuracy of dosage, and compressibility, and it has an impact on the solubility, duration of action, site of action, stability, and safety of the drug formulation. And the particle size control of drugs has an important influence on drug effectiveness, strength, and security. Therefore, particle size is an essential object of study in preformulation studies for innovative medicines. Preformulation research is a vital link in drug development, directly affecting the subsequent development process and final application of drugs. Preformulation research aims to determine the pros and cons of potential drug molecules at the initial research stage and to screen candidates for drug molecules, involving the synthesis of new drug molecules, biological activity screening, pharmacokinetics, toxicology, safety evaluation, etc...

  The vaccine is a generic term for various biological products containing antigenic substances that induce specific active immunity in humans. In preclinical studies of vaccine, it is crucial to examine the safety of vaccines by performing preclinical safety evaluations with relevant animals. Drug safety evaluation in preclinical studies of new medicines refers to the use of greater than clinical doses or more prolonged than clinical dosing times to administer drugs to animals to discover and evaluate the potential toxic effects on the animal organism, the manifestations of toxicity, and the reversibility of target organ damage. This study helps to find toxic doses, detect harmful effects, determine safe dose ranges, search for unhealthy target organs, and assess the reversibility of toxicity. The difficulty of drug safety evaluation in vaccines is that the vaccine does not directly exert preventive or therapeutic effects but acts by inducing the immune system to produce antibo...

  Toxicokinetics is an essential element of preclinical studies of drugs. As an interdisciplinary discipline between pharmacokinetics and toxicology, toxicokinetics is a bridge and tool for advancing preclinical studies to clinical studies. The primary goal of toxicokinetic studies is to demonstrate the systematic exposure levels of new drugs in test animals during safety evaluation and their correlation with the administered dose and the course over time. Their studies generally include single-dose studies in toxicity studies, multiple-dose studies, tissue distribution studies, genotoxicity studies, carcinogenicity tests, reproductive toxicity studies, and toxicokinetic studies for specific drugs such as biotechnology. Toxicokinetics is based on pharmacokinetic studies, with the help of its methods and tools, to help evaluate drug safety and regulate research behavior according to GLP. As new drug research progresses, some compounds to be selected (both small and large molecules)...

  According to the drug development process, new drug development can be divided into preclinical and clinical studies of new drugs. The former is the sum of all the research work done on a drug before it enters clinical trials, and the latter is the research work done on a drug in clinical trials. From the discovery of a drug's effectiveness in animals to its testing in human clinical trials, researchers do a great deal of work to ensure that the potential for a cure to be effective is maximized while minimizing the potential for harm. Medicilon is a preclinical research outsourcing (CRO) company that can provide customized preclinical trial service solutions to clients with years of experience in R&D technology and expertise in drug metabolism, Pharmacokinetics, pharmacodynamic studies, and toxicology. Preclinical studies of new drugs are essential to obtain the safety and efficacy of drugs, so how can we speed up the process? 1,Finding the best compound Finding the be...

Understanding Preclinical Research: The Key to Successful Innovative Drug Development   The first challenge in drug development is preclinical research of new drugs, which refers to chemical synthesis or natural product purification studies, drug analysis studies, pharmacodynamics, pharmacokinetics, toxicology, and pharmacology studies performed before a drug enters clinical studies. Preclinical studies of new medicines escort the development of innovative drugs.  To New drug registration, it's vital to conduct preclinical research, including studies on the synthesis process, extraction method, physicochemical properties and purity, dosage form selection, prescription screening, preparation process, testing method, quality standard, stability, pharmacology, toxicology, animal pharmacokinetics, etc. Chinese medicine preparation also includes the original herbs' source, processing, and concoction. Biologics has quality standards, preservation conditions, genetic stability, an...

  The purpose of drug development is to find new safe, effective drugs of high quality and stability to cure diseases and save lives. Developing a new drug is a very complex process, but it can be divided into  preclinical research   and clinical studies of a new drug.  Preclinical research is the first challenge in  drug development , and preclinical toxicity studies of new medicines are an essential part of the journey from the laboratory to the clinic. Since many studies closely related to the safety of subjects, such as drug distribution, reproductive toxicity, and carcinogenicity studies, cannot be performed on issues in clinical trials, animal experiments have an irreplaceable role.  However, there are differences between animals and humans, safety studies cannot be conducted on animal models alone, and normal animals do not respond to drugs the same way as patients. The humanized mouse model solves this challenge to some extent. Preclinical stu...

  In drug development, Radioisotope labeling has become a powerful tool. It provides a means to track the fate of drugs in the body and helps researchers to better understand the metabolic processes and potential toxicity of new compounds. So, scientists can design more effective and safer drugs, reducing the risk of adverse effects and increasing the likelihood of success in clinical trials. Isotopes are atoms of the same chemical element with different masses due to the presence of different neutron numbers in the nucleus, and there are light and heavy isotopes; based on physical properties, isotopes can also be classified into two forms: radioactive and stable. Radioisotope labeling technology is a very useful tool in the process of new  drug development , and Medicilon offers radioisotope services. Based on physical properties, isotopes can be classified into two forms: radioactive and stable. Radioactive isotopes (e.g. 3H, 14C) undergo their decay process and radiate radi...