We have all taken some kind of medicine, but what did pharmaceuticals do to get that medicine in the first place?
Although the pharmaceutical field has had significant advances over the past years, there has been some concern. The rising costs and reduced productivity can impact the patient’s access to many medications and treatments.
Understanding the basis of diseases, the translation of medical discoveries, and taking that into a safe and effective treatment, is a long process. This is a slow, costly, and hard procedure to go through, and it has a high failure rate.
There are many ways to gather research. It could be through the patient itself or companies can contract a research organization. Either way, research is the first step into developing a treatment.
Pharmaceuticals choose a gene or protein and then target it with a specific drug they think could work. Once they have a handful of potential molecules that could be involved with a disease, they go to the next stage.
The preclinical testing process takes the longest, and it’s the hardest to complete. There are two methods of testing:
This process involves studying the interactions between the drug molecules in lab tubes. Here, researchers will go down from thousands of possible molecules to approximately five.
In Vivo testing involves trying those possible drug molecules in living animals and cells. The FDA is pretty thorough with this stage, so the pharmaceutical company have to prove that the drug is safe to go to human trials.
Filing the Application
In this stage, the researcher will have to file an Investigational New Drug application into the FDA. This organization will now do the mandatory research into the preclinical trial results. Here they will look for:
- Side effects and safety features of the drug.
- Examine the chemical structure of the molecule.
- The manufacturing process for future treatment.
After the FDA approves the application, the human trial can start, and then the 20-year of exclusivity period for the patented drug begins.
Clinical studies are very sensitive because they’re dealing with human lives. In this stage, they will research about safety, effectiveness, and possible side effects.
The trial begins with a handful of healthy people, where the researcher can test the drug’s safety and process within the body.
The next step is to gather around one hundred people that are suffering from the disease in question. In this stage, the scientists will take a closer look at side effects, effectiveness, and the recommended dosage.
Afterwards, the testing involves thousands of people. If the results are promising, the company starts thinking about mass production.
Approval and Distribution
After the research is completed, the FDA will have to approve the drug. They will look into all the gathered research and results from the trials.
Then, when the drug is approved, the company can start distributing the medicine to people who are suffering from the disease.
Developing a drug is a really long and costly process; it can take up to twenty years! There are a lot of steps and safety measures involved so that the medication can work as expected without causing damage.