Who knows the standard process for the development of new chemical drugs?

There are six stages in the development process of a new drug:

1. Discovery of new compound entities.

2. Preclinical research.

3. Research new drug application (IND, i.e., application for clinical trial).

4. Clinical trial + preclinical research (continuation) supplement.

5. New Drug Application (NDA).

6. Listing and monitoring.

Among them, clinical research mainly includes:

Chemical synthesis: Providing sufficient quantities of compounds (drugs) for preclinical trials, clinical studies, small- and large-scale formulation preparation, and quality control and validation must be performed at every step.

Biological characteristics: pharmacology, drug metabolism, and other toxicology.

1) Purpose: To determine whether a compound has the appropriate safety and sufficient efficacy to continue to be a promising new drug, it is necessary to obtain information about how it is absorbed, its entire distribution in the body, its accumulation, metabolism and excretion, as well as its effects on the cells, tissues and organs of the body. It should be done by general biologists, microbiologists, molecular biologists, biochemists, geneticists, pharmacologists, physiologists, pharmacokineticists, pathologists, toxicologists, statisticians, etc.

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

3) Biological properties – drug metabolism.

4) Biological properties – toxicology.

Pre-prescription studies, including physicochemical properties, solubility, partition coefficient, dissolution rate, physical morphology, stability, etc.

3. Application for new drug research.

1) Submit an application (clinical research protocol).

2) FDA audit.

4. Clinical trials, generally including phase III clinical trials and studies, the number of cases in each phase has clear regulations in the country, and the time takes about 2-6 years.

5. New Drug Application (NDA): After the completion of preclinical and clinical studies, a New Drug Application (NDA) can be submitted for approval of new products.

6. Listing and monitoring: Phase IV clinical research and post-marketing monitoring, and then there are corresponding reports that must be submitted, and an annual report must be submitted at the time of one year.

Come up with ideas, validate ideas, experiment, process.

Generally speaking, once a new target of drug action is discovered, it often becomes a breakthrough for a series of new drug discoveries. To explain it in layman's terms, if the disease is compared to a lock, then the target is the lock cylinder, if the lock cylinder is found and the three-dimensional structure of the lock cylinder is studied, then we can find the lead compound according to its three-dimensional structure 02 computer-aided. Ambush related majors:

Medicinal Chemistry. Lead compounds: After the target is discovered, the spatial structure of the target is simulated by computer, and the fitting between the target and the spatial structure is carried out by computer because the spatial structure of different lead compounds is different.

I wish you a happy life! Hope mine is helpful to you ha.

Let's talk about the process of drug development from scratch to market.

i.Preclinical studies.

1.Confirmation of drug targets.

This is where all the work begins. Only when the target is determined, all subsequent work can be based.

2.Synthesis of compounds.

This stage of work is mainly responsible for the synthesis of new compounds, structural modification and optimization of existing compounds.

3.Screening of active compounds.

Not all synthesized compounds can have ideal activity, and at this stage, it is necessary to screen out the initially active compounds by biological experiments as candidates. These compounds are called leads. The obtained activity data can be combined with the compound structure to obtain a preliminary structure-activity relationship analysis.

The structure-activity relationship can effectively guide the subsequent structural optimization of compounds. This step is mainly at the level of cell experiments.

At the same time, there is also a situation where one compound has no effect on target A, but may have very good activity against other target B and target C.

4.Return to 2 for the next step of compound structure modification to obtain a more active compound.

2 to 4 This is a cycle until we get the desirable compound with enough activity.

The above is the approximate scope of work in the field of medicinal chemistry.

5.To evaluate the pharmacological effects, safety and toxicity of drugs, and the absorption, distribution, metabolism and excretion of drugs (ADME).

This part of the experiment needs to be done at the animal level. The results of cell experiments and live animal experiments can sometimes vary greatly. The purpose of this step is to determine the effectiveness and safety of the drug.

6.Development of formulations.

You can't just pour some compound into your mouth. Formulation development is an important part of drug application. For example, some drugs have poor gastrointestinal absorption, so they need to be developed into injections.

Some drugs will lose their activity in gastric acid, so they need to be developed as enteric-coated preparations. Some compounds do not have good solubility, which can also partially solve this problem with preparations.

All of these are collectively referred to as preclinical studies. It is the very beginning of drug development. The steps of the individual experiments are not necessarily strictly in this order, and there is no such clear dividing line. Each step is a mutually inclusive and coordinated relationship.

ii.Clinical research.

1.Phase I clinical trial.

2.Phase II.

3.Phase III clinical trial.

Just look at me: 8-10 years for fast, 15-20 years for slow.

The research and development of new drugs involves multiple disciplines, which is complex, time-consuming, and requires high funds. It sounds like a headache to say too much in detail, so I'll summarize it briefly to make it easier to understand.

It takes about 10 years + $2 billion for a new drug to go from R&D to marketing;

The launch of new drugs can be divided into four main stages:

1.New drug discovery stage: target confirmation, lead compound discovery, etc.;

2.Preclinical research: pharmaceutical research, animal experiments, etc.;

3.Clinical research: human drug experiments in the clinical period, drug efficacy evaluation;

4.Approval and marketing: drug declaration, post-marketing monitoring, etc.