The Food and Drug Administration is in control of drug development at all times. Research grants from private companies do not make a difference when the drugs still have to go through the rigorous processes set forth by the FDA. There are certainly plenty of good reasons why each stage of the drug development process happens as it does.
Creating a Drug
When beginning the drug creation process, there has to be something that capitulates its creation. This could be a charitable organization that is focused on creating a new drug to cure or treat the cause it promotes, or the discovery of a new compound found in the heart of the Amazon that could cure a major disease. Whatever the catalyst, the drug does not begin the first stage of development and research without applying to the FDA for clearance to begin this stage. In this way, the FDA keeps all records of every drug that is currently undergoing various stages of development.
The First Stage of Testing
The first stage of testing is always on lab rats or animals similar to humans, such as pigs. The results are recorded, and any extreme side effects or deaths are recorded too. The animals are then dissected to determine how and where the drug went wrong. Then the researchers return to the lab to tweak the drug and perfect it.
Second Stage of Animal Testing
There is always a second stage to animal testing. The purpose here is to get the drug safe enough to test in humans. That means that no animals die at this stage of testing, and the drug performs as expected. There has to be substantial proof to show that the drug works and will not hurt human test subjects. This proof is filed with the FDA along with an application to proceed with human drug trials.
First Stage of Human Drug Trials Through Production and Sales
When a drug developer gets the green light from the FDA to test on humans, then the first stage of human drug trials begin. Researchers are looking to see what side effects occur, how the drug responds to real human cells, and what positive effects are seen with the drug. If the drug is not quite ready, the researchers go back to the lab to see how to make it better. This process continues until there is enough evidence to show that the drug will really benefit humans. Then a patent is filed and the FDA receives an application for the license, production, and sale of the drug.
For more information about the steps you need to take to develop a new drug, contact companies like Drug Development Consultants.
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