Pre-clinical Research Escorts the Development of Innovative Drugs

The first challenge in drug development is the pre-clinical research of new drugs, which refers to the chemical synthesis or natural product purification research, drug analysis research, pharmacodynamics, pharmacokinetics, and toxicology that are carried out before the drug enters clinical research. And pharmaceutics research. Preclinical research on new drugs escorts the development of innovative drugs.

Preclinical research on new drugs for drug registration, including drug synthesis technology, extraction methods, physical and chemical properties and purity, dosage form selection, prescription screening, preparation technology, inspection methods, quality standards, stability, pharmacology, toxicology, Animal pharmacokinetics research. Traditional Chinese medicine preparations also include the source, processing and concoction of the original medicinal materials. Biological products include the quality standards, storage conditions, genetic stability, and immunological research of starting materials such as bacteria, cell strains, and biological tissues. Medicilon is a company engaged in pre-clinical research outsourcing services (CRO), which can provide customers with customizable pre-clinical trial service programs in drug metabolism, pharmacokinetics, pharmacodynamic research, and toxicology.

The safety evaluation research in the pre-clinical research must implement the “Non-clinical Drug Research Quality Management Practice” (GLP). The content of the pre-clinical research of the new drug includes the following content.

Medicinal Chemistry Research

Including the research on the physical and chemical properties of new drugs such as properties, molecular formula, structural formula, dissociation degree, PH value, physical constants (melting point, boiling point, freezing point, etc.), osmotic pressure, complexes, etc.; research on the process flow of new drugs such as route, reaction conditions, Production technology and refining methods; research on antibiotic strains and culture media; research on chemical raw material specifications; research on sources, scientific names, drug names or extraction parts of animal and plant raw materials; research on formulations, technological conditions and refining processes; basis for compound preparations, Research on the specifications and sources of excipients.

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Pharmacodynamics Research

Generally, it includes three aspects: main pharmacodynamic research, general pharmacological research and research on compound preparations. Pre-clinical pharmacodynamic evaluation is based on the early research of new drugs, and further systematically evaluates and compares the drug efficacy of candidate new drugs, drug in vivo process, drug safety and key technology of action mechanism. It is the key technology of new drug development and new drug entering clinical research. Key link. However, for a long time, too much attention has been paid to safety, and less attention is paid to effectiveness and action characteristics. The pharmacodynamic evaluation still lacks guiding principles and research standards. For a long time, my country’s drug efficacy evaluation work still has a large gap compared with western developed countries in terms of systemicity, standardization and reproducibility. This has affected the quality of my country’s innovative drug research and development and its globalization to a certain extent. Therefore, reducing subjective factors, increasing the scientificity, standardization and repeatability of pharmacodynamic evaluation, drawing on advanced experience at home and abroad, and better guiding clinical research are the main tasks of preclinical pharmacodynamic evaluation in the future. A standardized pharmacodynamics and evaluation platform that is in line with international standards is very important to promote the research and development of innovative drugs in my country.

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Pharmacokinetics Research

Mainly refers to the research on the absorption rate, the degree of absorption, the distribution of the internal organs, and the rate and degree of excretion of drugs. Pharmacokinetics is an indispensable and important research content in the development of innovative drugs, and even determines the fate of drug development. Pharmacokinetics is a multidisciplinary subject that quantitatively studies the absorption, distribution, metabolism, and excretion of drugs in the body (ADME). It also integrates pharmacology, drug analysis, pharmacy, traditional Chinese medicine, cell biology, and molecular biology. , Experimental zoology and other related knowledge. The application research of pharmacokinetics mainly includes the pre-clinical evaluation and application of innovative drugs, the clinical pharmacokinetic research and evaluation of new drugs, and the pharmacokinetic research of traditional Chinese medicine and biomacromolecule drugs.

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Toxicity Test

Understanding the mechanism of toxicity can truly solve the problem from the root cause. From the perspective of drug discovery and development, studying the mechanism of drug toxicity can increase and improve the relevance of drug safety evaluation. Generally speaking, toxicologists often analyze the following basic questions to study the molecular mechanism of toxicants, such as how does the toxicant enter the body or cell? How is it distributed and metabolized in the body? How does it interact with target molecules? How to exert its toxicity at the molecular level Effect? How does the organism respond to poisonous attacks? What are the downstream biological consequences of poisonous attacks?

In the development process of a new drug, the first thing to overcome is the efficacy, and then the safety evaluation in terms of toxicity will be carried out. However, in the development process of many candidate drugs, due to the lack of pharmacological-toxicological data basis for a certain series of drugs in a certain field , Or the person in charge’s ability to predict some structural fragments is not enough. When a large amount of manpower, material and financial resources are invested, and the project gradually progresses to large animals, sometimes there will be a “painful” toxicity problem, and at this time, for For the team, it was extremely embarrassing.

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Research on the Stability of New Drugs

Mainly include chemical stability, physical stability and microbial stability. Stability research is based on the systematic research and understanding of APIs or preparations and their production processes. The quality characteristics of APIs or preparations obtained through design experiments will vary under the influence of various environmental factors (such as temperature, humidity, light exposure, etc.). The laws of time change, and based on this, provide supporting information for the determination of the prescription, technology, packaging, storage conditions, transportation, use, and expiration date/re-inspection date of the drug. Drug stability research is a process of comprehensive quality assessment of drugs using scientific analysis methods and principles, and plays an important role in the entire life cycle of drugs.

The purpose of pre-clinical research work is to understand as many aspects of drugs as possible before they are used in humans, thereby minimizing risks. No one is willing to take drugs that may or may not contain toxic excipients, and no one is willing to take drugs with an indeterminate amount of active ingredients. Therefore, even in the pre-clinical stage, developers must be able to show that they are capable of producing accurate and identical drugs at any point in time, even in the case of mass production.