Medicines have enabled us to mitigate all sorts of injuries, aches, pains, and symptoms, as well as reduce the duration of illnesses. Besides the potency and efficacy of our medications improving our health, our social systems around medicine have improved, too. For instance, online pharmacies make it easy to have a prescription fulfilled and doorstep delivery of medicine makes it easier for people who can’t leave home to get their medications.
Although most people take at least one type of medication, we seldom pause to think about how these medications are developed and the stringent scientific tests they go through. Yet, in fact, the laboratory process is so rigorous that when a laboratory has to move to a new location for one reason or another, the scientists and technicians don’t do their own packing. Instead, the laboratory will hire an outside firm like Pacific Bio Material Management, Inc., to make sure that bio-repository and bio-transport regulations are met and that the compounds and specimens under examination are not contaminated during the move or damaged by temperature fluctuations.
There are five essential stages when it comes to the scientific examination a medication must go through before it is approved for sale: discovery and development, pre-clinical research, clinical research, the FDA drug review, and the FDA drug monitoring.
Let’s take a closer look at each stage to understand the meticulous nature of the drug manufacture process:
First Stage (Development and Discovery)
The research necessary for a new drug will start in the laboratory. This research is broken up into two phases: discovery and development. During the discovery stage, hundreds of compounds are considered for developing a medical treatment for a disease. Then, during the development stage, when the most promising compounds have been earmarked for further study, experiments are conducted to gather as much information as possible about their mechanisms of actions and benefits.
Second Stage (Preclinical Research)
During the pre-clinical stage, the drug is tested on animals to satisfy safety issues. These studies are small in scope and focus on reviewing dosage and toxicity levels. Researchers want to make absolutely certain that the drug is safe enough to test on people.
Third Stage (Clinical Research)
During the clinical research stage, drugs that have passed the pre-clinical screening process are now tested on people to answer some basic questions. First, researchers want to know if the drug is safe. Once that’s determined, then they want to know if it’s effective. Clinical trials are designed to address these two main issues.
Researchers now decide how many people to involve in the study, how long the study should last, how the drug will be administered, and so on.
Fourth Stage (Passing the FDA Drug Review)
Once the researchers are satisfied that they have found a safe, effective drug that offers benefits to people with a certain illness, they then ask the US Food and Drug Administration (FDA) to review their findings. The FDA will assemble a team of scientists to go through all the data that has been submitted to them and decide whether the drug should or should not be approved.
Fifth Stage (The FDA’s Post-Market Drug Safety Monitoring)
Although the FDA has approved a drug, it’s always possible that the drug turns out to neither as safe nor as effective as was previously believed based on clinical evidence. If doctors or patients report problems with the drug, the FDA will troubleshoot the issue. They will review dosage and usage information to find out the cause of the complaints. It’s possible that the drug may simply need more cautious labeling on dosage or usage, or, in a worst-case scenario, the drug may pose problems that the researchers and the FDA review team missed. If serious side-effects are discovered, the drug will be recalled from the marketplace.
In conclusion, learning about the rigorous steps a medication must go through before its released to the public is useful information for numerous parties. It’s useful for consumers who benefit from a better understanding of how to stay safe and healthy. It’s useful for patients who want to find out about various treatments available. It’s useful for health professionals who notice adverse effects in their patients and need to report them. It’s useful for scientists and researchers to improve their clinical methodology. And it’s useful for business and industry who can offer both drug makers and consumers any necessary guidance on what changes that need to be made in the manufacture or sale of medication.
