New Drug Synthesis

When a scientist develops a new drug and believes it is ready for people to try, he or she has to go through a process with the FDA to get the drug approved and ready to make it into a person 's everyday life. Most people do not know the process of how a drug goes from chemicals, or any of the substances placed in a medication, to the pill, IV, nose spray, etc. that a patient has in his or her hand. The FDA has a long process that a drug has to go through before that patient can hold it. After a scientist come ups with the makeup of the drug, he or she has to do laboratory tests to check for side effects. If the tests come back good, an Investigational New Drug application must be submitted. If the application is accepted clinical trials must …show more content…
Phase I clinical trials start with a small amount of volunteers to test the safety. After determining dosage and side effects, the drug moves to Phase II and Phase III clinical trials. Susan Thaul wrote about the Phase II and Phase III clinical trials in How FDA Approves Drugs and Regulates Their Safety and Effectiveness saying, “Those trials gather evidence of the drug’s efficacy and effectiveness in larger groups of individuals with the particular characteristics, conditions, or disease of interest, while continuing to monitor safety.” Without going through the trials, the scientists would not know the safe amount to give a person or the side effects. These trials help patients know the same amount of the drug to use and what to look for if something goes …show more content…
Not every drug can pass all the steps of the approval process. All this information is important in the drug process, but what does it have to do with respiratory therapy? Drugs can pass this process at any time, and these drugs can affect respiratory therapy. If a new drug comes out that affects the respiratory system, a therapist will need to know all about the drug. He or she will need to know how the new drug works, the side effects, what it does for the patient, and what is in it. Not all drugs are made for the respiratory system, but knowing the process of how a drug comes about can help a person understand the drug itself and this can help to know when to use the drug. In my clinicals, it is good to know the process so if a new drug comes out I know how it came to be. Most people do not think of the process of the drug coming to be, but it is good to know and understand incase you have to use a new drug. This process weens out the drugs that may cause more harm than good. Starting as a combination of chemicals and substances to becoming a drug that a person may take on a day to day basis needs to involve all the above steps to make sure it is safe for the person taking