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Discovery and development of pre-clinical vitamin drugs (chemical drugs)

2021-03-02
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It is an extremely long and costly process. According to statistics, the average cost of new drug research and development is 2.6 billion U.S. dollars, which takes 10 years, but its capital return to successful people is also extremely rich. How to improve R&D efficiency and reduce the probability of R&D failure is a difficult problem for every pharmaceutical company.

preclinical drug research
preclinical drug research

Among the 150 additive drugs in the drug discovery stage, only one enters clinical development, and the average incidence of final approval for marketing of alternative drugs approved by the FDA is about 1/10. For large pharmaceutical companies, there are more incentives and funds to support projects and promote expansion of drugs to the market. For smaller companies, alternative drugs in clinical trials will greatly increase the chances of attracting investors.

drug discovery
drug discovery

Drug discovery

The drug discovery phase begins with the determination of the target. Finding and determining the target is this step in the drug development pathway, and it is also the most important step. Drug targets are biomolecules with important physiological or pathological functions that can be combined with drugs and produce pharmacological effects and their specific binding sites, including receptors (about 50%), enzymes (20%), ion channels ( 6%), nucleic acid (3%), etc. Click the interactive sprout compound (clicks), and design a possible lead compound (leadcompound) based on the three-dimensional structure of the target. Optimize these lead compounds so that they can be as effective as drugs. GLP laboratory is carried out, but it needs to have more innovative thinking and problem-solving ability.
According to statistics from IDEA pharmacies, between 2008 and 2017, a total of 846 phase III clinical trials failed, 50% of which were due to failure to recruit patients. The establishment of a project is likely to misjudge the market share and prospects, and even lead to insufficient patients to support clinical trials.
Many parameters such as cell permeability, plasma stability, plasma protein binding, plasma clearance, etc. will affect alternative drugs in the body. Therefore, the most effective lead compound in the body is selected as a preclinical additive drug.
The cost of new drug development is very expensive. Therefore, the determination of preclinical alternative drugs is an important substitute for fault-tolerant substitution in the process of drug discovery and development. According to the different indications of the disease, the cost of drug development and the preclinical toxicological and pharmacological studies required for IND applications are also different. But under normal circumstances, an alternative drug needs to spend about 1.5 million US dollars, 9-12 months to complete the research required to submit the IND. Authorized research is unrealistic, and it is necessary to adopt strategies to determine a pre-determined drug.
When determining the target drug, in addition to commercial factors, it is also necessary to evaluate the efficacy, safety, pharmacokinetics and toxicology. Hygroscopicity and intellectual property rights are also factors that cannot be ignored in the final choice.

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