Four crucial steps to developing a drug according to FDA

If you don’t know, the development process of new drugs is not as easy as it may sound. Most pharmaceutical companies can take between 12 and 15 years from starting to research an active ingredient until it is available to patients. It is a very extensive process that requires a high economic investment by pharmaceutical companies. Mainly the process can be summarized in 5 steps.

Discovery and development

Therapeutic targets that indicate the development are identified in the very first stage. Targets are chemical substances that are associated with disease. Once the target has been identified, its mechanism is studied. Following this analysis, various tests are performed to see which compounds have the desired effect on the selected target.

Pre-clinical research

Before testing in humans, researchers must ensure that the compound is safe for human consumption. For this, studies are carried out in the laboratory such as -

• In vitro: these are studies that are performed on cells or tissues from glass or plastic containers.

• In vivo: these are tests that are carried out in the body of living organisms.

Pre-clinical research should provide detailed information on the possible doses that can be administered and the levels of toxicity. After these results, the researchers evaluate whether the drug candidate can be tested in humans.

Clinical research

Clinical research refers to studies or trials that are carried out on human beings to test how the drug interacts in the human body. Before starting this phase, researchers must deliver to regulatory agents the IND document, where the results of the pre-clinical research and the protocol of the clinical trial in humans to be carried out are presented. Clinical trials are conducted in phases (4 phases) ranging from small to large scale.

Registration and authorization of the authorities

Once the researchers have the results and analysis of the clinical trials, they proceed to send the NDA to the corresponding regulatory authorities. The NDA contains all the information about the drug where its safety and efficacy are demonstrated in the population studied. If the authorities see the safety, efficacy and quality of the new treatment proven, authorization is granted to market it. Once the product is marketed, new clinical trials can be carried out to determine its effectiveness for other indications.

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Source: 

https://www.bloglovin.com/@aaryan27/four-crucial-steps-to-developing-a-drug-according