Who knows the standard process of developing new chemical drugs?

There are six stages in the research and development of new drugs:

1, Discovery of New Composite Entity

2. Preclinical research

3, research new drug application (IND, that is, apply for clinical trials)

4, clinical trials+preclinical research (continued) supplement

5. New drug application (NDA)

6. Listing and monitoring

Among them, clinical research mainly includes

2. 1 chemical synthesis: to provide enough compounds (drugs) for preclinical trials, clinical research, small-scale and large-scale preparation, and each step must be subject to quality control and verification.

2.2 Biological characteristics: pharmacology, drug metabolism, toxicology, etc.

1) objective: in order to judge whether a compound has proper safety and sufficient effectiveness, so that it can continue to be a promising new drug, it is necessary to obtain information about how it is absorbed, its overall distribution in the body, its accumulation, metabolism and excretion, and its effects on cells, tissues and organs of the body. General biologists, microbiologists, molecular biologists, biochemists, geneticists, pharmacologists, physiologists, pharmacokinetics, pathologists, toxicologists, statisticians, etc. Should be involved in this project.

2) Pharmacology: Evaluate the biological activity of chemical substances and determine the mechanism of drug action.

3) Biological characteristics-drug metabolism

4) Biological characteristics-toxicology

2.3 Pre-prescription research, including physical and chemical properties, solubility, partition coefficient, dissolution, physical morphology, stability, etc.

3, new drug research application

(research new drug application, IND)

1) Submit application (clinical research scheme)

2)FDA audit

4. Clinical trials generally include three stages: clinical trials and research. The number of cases in each stage is clearly stipulated by the state, which takes about 2-6 years.

5. New Drug Application (NDA): A new drug application (NDA) can be submitted before and after the clinical research is completed, so as to be allowed to market new products.

6. Market monitoring: the fourth stage of clinical research and post-market monitoring, and then the corresponding report must be submitted, and the annual report will be submitted one year later.