There is an extensive process to the release of new pharmaceuticals on the market. Have you ever wondered how your favorite and most trusted over the counter drugs have come to the shelf? It is likely that this process started many years ago. Even if the drug has been designed and completely finished for many years, it still takes a while to be released to the public. These are the most important steps involved in clinical drug development.
The initial design and production
When a pharmaceutical company identifies a problem and a need for a new drug, they begin the research and design process. This process itself can take many years to complete. Once the initial design is completed, the product will be produced. Sometimes, this process is repeated over and over again, until a final product is created. Once the final product is produced, the drug still does not make it to the shelf. It might first go through an entire clinical drug development that includes numerous clinical trials.
Phase 1 clinical trials
The first phase, also known as the phase 1 of clinical trials is when the drug is given to the smallest population of people. The side effects have not yet been classified, so it could be dangerous to give it to too many patients. The patients in these studies are voluntary and may be completing the study for income or to treat a medical condition that no current pharmaceutical has been successful at. Patients have to demonstrate informed consent here. This is a psychological term that means they were notified of potential problems and that they are committing to the clinical study completely voluntarily.
Phase 2 clinical trials
Phase 2 has worked out all of the initial problems with the drug. It is possible that changes were made and the drug has been re released at this point in the medical research studies. In phase 2 studies, the experimental drug or treatment is administered to a larger group of people (100 to 300) to determine its effectiveness and to further evaluate its safety. Just because the drug has reached the phase 2 of the clinical drug development does not mean that it will not have to go back to phase 1 at some point. It also means that it is not yet approved for mass production or consumption.
Phase 3 clinical trials
Phase 3 is the next part of the clinical drug development process. The drug is now given to an even larger group of patients. Even more information is gathered and this information is used to improve the drug and to list the possible side effects. Side effects can be evaluated better in this clinical stage because there are a larger number of people taking the drug. If too many people experience harmful side effects, the drug might be pulled off the market at this stage.
Phase 4 clinical trials
This is the final stage of the clinical drug development process. This is where the final testing will take place. After completing this phase, the clinical trial team submits a New Drug Application (NDA) for approval to go on the market. Of the 5,000 to 10,000 drugs that annually enter this phase, only about 250 will make it to pre clinical trial testing, only five make it to clinical trial testing, and only one will make it to FDA approval. Even successfully making it through the four stages of the clinical drug development process does not guarantee that it will be released to the public.
You have probably thought very little about the release process of the drugs you purchase off the shelf. These drugs go through an extensive and long clinical drug development process. Even completion of this process does not guarantee FDA approval or public release. The medications that you use on a daily basis have gone through an extreme process to ensure that they are safe and useful for you.