Animal Testing Process

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The creation and release of a new medication is a time consuming and expensive production, and there are several stages of testing to get approval from the FDA. It all starts with a newly discovered or recently redesigned drug. The drug company must submit an Investigational New Drug Application (IND) to the FDA after completing animal testing, which may or may not give them permission to go into clinical human trials, which has three phases. The drug company must then agree to follow up studies of the after effects. Finally, the drug company has to turn in another IND, this one containing all of the data from the entire testing, animal and the three stages of human results. There are a few other small steps along the way, as the FDA has to approve of the manufacturing site and the professional packaging insert. (FDA) This complicated process takes several years, and then the FDA takes 10 months to determine if the drug is marketable. The FDA has a specific set of guidelines to thoroughly test new drugs to determine its safety and effectiveness prior to approval for marketing. There are multiple stages of testing and the first step is in vitro testing (Latin for in glass), which is done in test tubes to chemically analyze the drug. Next comes in vivo (Latin for in living) which is both animal…show more content…
They are looking at the number of animals that do or do not respond, the half-life of the drug, or the amount of time it takes the body to dispose of 50% of the drug, the therapeutic effective levels of the drug, somewhere between ineffective and toxic. Once the animal testing is complete, an IND is submitted and if approved, human trails may begin. The vast majority of drugs fail to make it to human trials, only 10% pass into human testing, and of this only 1 in 5 will make it to
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