How do Medicines Get Made?

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Medicine is an essential part of our lives, ensuring that we can stay happy and healthy. However, many people don’t actually know how medicine is made or what processes it has to go through. Many people are rightfully wary of what they put into their bodies, but companies like Adare Pharmaceuticals put extensive efforts into producing safe and effective medicine. So how exactly are medicines made, and how do companies and the government ensure that the medicine you’re taking is safe? Let’s take a look. 

Discovery

The first step in the long process of creating medicines is the discovery of a potential medicine. Scientists and researchers may come up with new ideas on their own, or other research and tests may have unexpected results and lead to new ideas forming. These new ideas are then developed into medicinal products, as researchers attempt to discern the best form of the medicine, what the correct dosage should be, or any negative side effects the medicine might bring about. Thousands of potential medicinal candidates are tested every year, but very few make it past preliminary development. The human body is very complex, so finding formulas that can solve problems without causing major adverse effects is difficult for researchers and developers. 

 

Research

Once a potential medicine has been discovered and developed, it needs to go under further extensive research. During this period, scientists first start their research on animals, testing to see how the medicine interacts with their bodies. Researchers do this step to ensure that the medicine is safe for consumption and isn’t toxic. When a medicine passes animal testing, it then moves to clinical trials. Two groups of human testers are made, with one receiving the medicine and one receiving a placebo pill. The progress of the two groups is monitored to ensure that the medicine is actually effective and that no major damage is caused to the human body from the medicine. Rigorous testing and research need to be done before medicine can even come close to the open market, as researchers need to make sure the drug is completely safe. There are many factors to consider, so the research stage could take a considerable amount of time. 

 

Safety Reviews

Once a medicine has gone through rigorous testing and is deemed safe for use by the producer, it must be submitted to the Food and Drug Administration for review. The FDA will review testing results to ensure that they are aligned with FDA standards. Additionally, the FDA may even travel to testing sites to ensure that the results of tests weren’t manipulated or tampered with. An entire team is assigned to review, and each member meticulously combs through the medicine’s history to find any problems. Once a decision is made, the review team makes a recommendation on the drug before sending it to a senior FDA official to make the final decision. If the medicine has been accepted, the makers can begin marketing and distributing it to the public. However, if the medicine is declined, more tests and studies need to be conducted before it can hit the open market. 

 

Public Monitoring

Even when a medicine is approved and in the open market, it still is not completely free from further review. Once a medicine has been approved, the FDA continues to monitor how it affects the public. During this process, the FDA will gather results to see if the drug is actually effective at treating the targeted illness. Additionally, the FDA will ensure that no major side effects or accidents are caused by the drugs. If the drug proves to be dangerous or ineffective once it hits the public, the FDA will pull it from the open market. 

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