The process of creating new pharmaceutical drugs is a long and complex one. The task begins with a team of dedicated scientists who work to identify a new drug target based on illnesses that plague the population.
The end result is medications that improve the quality of life for patients all over the world. Let’s talk about what steps take place before this can happen.
The Target
The people in charge of formulating drugs are called medicinal chemists. They have to be able to understand the root cause of an illness in order to identify potential targets for new drugs.
This is no easy feat – it can often take years or even decades to find a new target. Once they’ve found one the next step is to develop a compound that can bind to and interact with that target. This process is known as drug discovery and it can take many years to complete.
Compounds
A compound is a small molecule that has the ability to interact with a target. To find new compounds, scientists screen large libraries of chemicals.
This is usually done using computers and automated systems. This part of the process is akin to searching for a needle in a haystack, and while there may be many compounds that will interact with a target, the way they interact may or may not be promising.
Once promising compounds are found, they must undergo further testing which eventually leads to a compound that is promising enough to begin testing to see if it is safe and effective.
The FDA
Once a promising compound has been found, it must then undergo extensive testing in both laboratory settings and clinical trials.
These trials are necessary to determine the safety and efficacy of a new drug. This process also documents the statistics for various side effects and interactions with other medications.
The data from these trials are then submitted to the FDA for approval. This step is detailed and involved so companies like Compliance Insight specialize in navigating through that process, helping with a host of compliance-based procedures needed before taking the drug to market.
The Market
After a new drug is approved by the FDA, it is then made available on the market. This process begins with marketing and advertising the new drug to doctors and patients.
Even then, the drug is continually scrutinized by the FDA, which can order changes to the manufacturing process or recall the drug entirely if it is found to be unsafe.
Creating new pharmaceutical drugs is a long and arduous process, but one that can have a profound impact on the lives of patients all over the world. The next time you take medication, remember the years of research and development that went into making it.
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