What Are The Steps In Drug Development?

There are a lot of companies that are working hard to produce medications we can use to treat a variety of injuries and illnesses. For example, during the past few years, a significant amount of attention has been focused on developing medications that can treat the coronavirus pandemic. At the same time, it is exceedingly difficult to develop new drugs. There is a reason why they don’t come out very often, and there is a reason why the process is so long. It is important for researchers to make sure the drug is both safe and effective before it reaches the open market. What are a few of the steps involved in developing a new drug?

Identify a Target for the Treatment Process

One of the first steps in the drug development process is to identify a target for the treatment process. For example, if someone is developing a new drug for the coronavirus pandemic, they need to find a target. Obviously, the target is the virus, but what part of the virus are they going to target? The goal is to create a drug that will bind to the virus without harming the human host. Therefore, there might be a specific protein that is indicative of the virus. Someone might try to create a drug that targets that specific protein as a way to kill the virus.

Test the Drug in the Lab

The next step is to test a drug in a laboratory setting. For example, researchers might engage in assay development to synthesize drugs that can target that specific injury or illness. They will create a hypothetical set of conditions in the lab. Then, they will develop the drug in the lab. After that, they will take the drug and administer it to the target in a lab setting. They will put everything under the microscope and take a look at the results. Did the drug work? If the drug did a good job of hitting the target, then it might be time to move on to the next set of trials.

Test the Drug on Animals

If that worked well, then the next step is to test the drug on animals. There are some animal models that are relatively close to humans in terms of organ structure and function. Therefore, they can make a great substitute for people for an unproven drug. Researchers will try to locate animals that have similar conditions to those being tested. They might also intentionally give the animals whatever they are studying. Then, they will administer the drug to see what happened. They are looking to see that the drug not only works but is also safe. This is the first opportunity for researchers to identify potential side effects or complications that could require the drug to be altered.

Test the Drug on People

If this goes well, the next step is to test the drug on people. The research group will ask for a set of volunteers that have whatever injury or illness is being targeted. Then, they will ask everyone to consent to be treated with an unproven drug. Usually, the research study participants are compensated for their time. Again, the research team is trying to make sure the drug is not only safe but also affected. They will keep a close eye on the research participants, and they may need to alter the drug before it reaches the open market.

Release The Drug With Close Monitoring

Finally, if the drug has been shown to be safe and effective in clinical trials, it can be released to the open market. At the same time, this doesn’t mean the monitoring process is done. It means that the drug still has to be followed carefully to make sure there are no new side effects that develop. Every drug on the market is watched closely. All the information is reviewed from time to time to make sure nothing goes wrong. If there are any concerns related to the drug, then it could be recalled. Even though it is a long process, the steps are in place for a reason. It is important to make sure every drug on the market is both safe and effective.


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