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Accelerated Development or Review of Drug

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Accelerated Development or Review of Drug

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If Tom's drug had serious life-saving potential his drug would undergo acclereated devlopment or review, which makes the drug development process faster for drugs like his that show serious potential in terms of treating life-threatening diseases.

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Tom is are filling out the Investigational New Drug Application for his new drug. He fills out information related to the manufacturing of the drug. He also includes proof that the drug is safe for human testing. The proof is through animal studies that were conducted with your drug. He also includes potential clinical studies/human testing procedures. This application allows for his company to give the drug to investigators in various states.

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Tom, being very self motivated and being interested in business and chemistry, also studies the drug during the discovery/preclinical phase for 3-6 years. He tests the drug on no or a minimal amount of humans. He is trying to determine the best potential chemical makeup of the drug, so he runs tests with different chemical makeups of the drug and determines which chemical makeup is the best. The feeling he got after determining the best chemical makeup, after all the late nights in the lab, was amazing!

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Quacker is another subject and he is studied over the long-term. There are a several thousand other subjects. He is being studied to determine what the long term effects, other than the vaccine's intended effect, are on the the person and also to determine the overall long-term safety and effectiveness of the vaccine. So, the investigators will observe any side effects he has and will examine how safe he is medically and how effective the vaccine was on him, again, in the long term. Side note: Quacker LOVES to swim!

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Spike the dog is another subject in clinical trials and is contacted many times in 1-3 years. There are 300-3000 other subjects. He is being tested to detect negative reactions to the drug. So, he will be given the vaccine and the investigators will see if he reacts in a negative way. However, Spike is not the most cooperative subject!

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Butch Cat is another subject in clinical trials and is contacted many times in several months to two years. There are 100-250 other subjects. He is being tested to determine what the effects the vaccine has on the person are other than its intended effect. He is also being tested to determine how effective the vaccine is overall. So, he will be given the vaccine and the investigators will see if he reacts in any odd way and they will see how effective the vaccine was on him. Here, Butch cat is taking an oral test vaccine!

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Jerry is a subject in clinical trials and is contacted many times in several months. There are 20-100 other subjects. He is being tested to determine the safety of the vaccine and the amount of the vaccine that should be given each time a person takes it. He is given various doses of a vaccine and the investigators see how he reacts each time.  But first, Tom must call Jerry and ask him if he is interested in becoming a subject!