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I often hear people claim that they never go to the hospital, but few people dare to say that they never take medicine. one

Individuals, from birth to death, will get sick more or less inevitably. When you are sick, you will inevitably have someone to talk to.

Modern medicine provides various effective drugs for many diseases, but it also

There are many diseases that can't be cured without specific drugs. Therefore, people still need to constantly develop and constantly look for new ones.

Medicine. Every moment, advertisements on TV and newspapers are spreading some incurable diseases to us.

The good news of the new drug makes patients and their relatives and friends feel heartache. However, this is often nothing more than cheating money.

Sweet words. Take care of your wallet, don't be tempted by false drug advertisements, and avoid losing both money and money.

Hope, it is necessary to know a little common sense of new drug research and development.

In the past, the discovery of a drug was often a kind of luck, but now, people are increasingly targeting a certain disease.

Patients consciously design and develop new drugs. The development of modern drugs is a big military battle and needs many different fields.

Cooperation of subject experts. It needs physiologists, biochemists and molecular biologists to study in cells.

At the molecular level, we study physiology and pathology and design drugs, organic chemists synthesize drugs, and toxicologists study drugs.

Toxicology of substances, pharmacopharmacology studied by pharmacologists, simulation analysis by computer experts, and drug treatment by doctors.

Conduct clinical trials and observe the curative effect, statisticians count the treatment results, and so on.

The first step in the development of new drugs is to study the physiological functions of the human body. Physiologists study the human body.

Under normal conditions, biochemists study chemical changes in the course of life.

Molecular biologists study the functions and interactions of various molecules in the process of life. In this way, we will

We can understand how our body is in a normal state from different levels of molecules, cells, organs and human body.

Surgery, and what kind of abnormality the lesion is due to. The occurrence of a disease is a series of very

A complicated process. If we can crack this process at the cellular and molecular level, we can trace it to the end.

Which step is wrong can provide ideas for the design of new drugs: if there is abnormality in this aspect,

Step by step aiming, adding a compound with special structure or properties, how will it change the molecule and fineness?

Will the physiological activities of cells correct the pathological changes and achieve the purpose of treating diseases?

Sometimes, researchers can find this special compound quickly, which is very lucky. more

Sometimes, researchers need to screen thousands of compounds to find some effective compounds. at present

Researchers can use computers to simulate targets, design their chemical structures and tell chemists that they should do so.

To synthesize compounds with what structure and properties, so as to narrow the screening range.

First of all, the test of pharmaceutical compounds is carried out in test tubes and cells cultured in vitro. In a test tube

In the experiment, drugs directly act on the target, which is easy to produce obvious effects, but it is not necessarily the same.

Will be effective for the human body. Drugs may not be absorbed by the human body, and those that can be absorbed by the human body may not be able to be sent.

It works, but it may also have adverse reactions to the human body. These are not observed in in vitro experiments.

However, for humanitarian reasons, we can't just take people to do experiments. Therefore, the next stage, research

Researchers need to do animal experiments.

Commonly used experimental animals are mice, rats, rabbits, cats, dogs, monkeys and so on. When doing animal experiments,

It is necessary to use two or more kinds of animals, because different kinds of animals may have different reactions to drugs.

First of all, we need to know what kind of effects drugs will have on the body and test drug compounds on animals.

What is the effect, what kind of toxic and side effects are there, and the dosage is safe. Secondly, we also need to know about the body.

For example, how to experience the reaction to drugs and how much drugs will be absorbed into the blood, which is in

How the body metabolizes and decomposes, whether its metabolites are toxic, and the excretion of drugs and their metabolites.

How soon? Wait. If the active ingredient of the drug cannot enter the blood, or although it enters the blood,

But the speed of metabolism, degradation and excretion is too fast, so it is useless. At this time, people should consider it.

Whether to change the chemical structure of drugs or add other chemical components to help drugs be absorbed or slow down their metabolism,

Degradation and excretion rate. Sometimes, people will find that the metabolite of a drug is even worse than the drug itself.

More effective.

However, the physiology of animals and humans is still different after all. Drugs that are effective for animals and have little toxic and side effects,

Not necessarily for the human body. Only clinical trials can finally determine whether a drug is effective and available to the human body.

What are the side effects? Once a drug has passed in vitro and animal tests, it seems promising to become a new drug.

You can apply to the Food and Drug Administration for clinical trials. Clinical trials are usually divided into three different stages, called

Phase I, II and III clinical trials.

Phase I clinical trials are short-term and small-scale. The subjects are usually 20- 100 people, healthy volunteers or patients.

Both will do. Its main purpose is to observe whether the new drug will have acute toxic and side effects, and to test the appropriate safe administration.

Dose, and a preliminary study of human absorption, metabolism and excretion of drugs. The time lasted for several months. If it is not strict

Serious problems, such as unacceptable side effects, can enter phase II clinical trials. About 70% of drugs can be used.

Successfully passed this stage of the experiment.

Phase II clinical trials are medium-term and medium-scale. The research object is patients, usually 100-300 people. primary

The purpose is to observe whether the new drug is effective and further observe the short-term safety. It lasted for several months.

To two years. Only about 33% of new drugs can successfully pass this phase of the trial and enter the third phase of clinical trials.

Phase III clinical trials are long-term and large-scale. The research object is patients, usually 1000-3000 people. purpose

It is to confirm the efficacy and safety of new drugs and determine the dose. For one to four years. About 25-30% of new drugs

Can pass the test of this stage.

After the completion of phase III clinical trials, pharmaceutical companies can apply to the drug regulatory authorities for listing.

The supervision department organizes expert appraisal. In the United States, new drugs are finally approved by the Food and Drug Administration (FDA).

It only accounts for 20% of the total number of new drugs initially applied for clinical trials.

Sometimes, in clinical trials, a drug is found to be effective in treating malignant diseases, which will

Stop the clinical trial in advance and use it directly to treat patients. For example, AZT, the first new drug to treat AIDS.

After only 106 days of clinical trial, it is found that it can significantly improve the survival rate of patients.

The drug administration immediately suspended the clinical trial in advance and allowed it to be used for treatment before approving its marketing.

More than 4000 AIDS patients.

After a new drug is approved for marketing, it is usually necessary to further observe the long-term clinical response of the drug in a large range.

Comparing the efficacy and safety of this drug with other existing drugs is called phase IV clinical. Because I'm doing it

Children, pregnant women and the elderly are often excluded from bed tests, so it is especially necessary to observe new drugs after they are put on the market.

The safety, efficacy and dosage range of drugs for these people and some specific patient groups in order to obtain a more complete

Superficial information. If it is found that serious unexpected side effects will occur after long-term use, the drug may be

Recall from the market immediately.

Developing new drugs is a very time-consuming and expensive process, which small companies can't afford.

In the United States, the development and approval of a new drug takes an average of 8.5 years and costs hundreds of millions of dollars. each

Of the 5,000 candidate drugs, only 5 can enter clinical trials, and only 1 can be finally approved for marketing.