FDA Approval Chart.docx - Running Head FDA APPROVAL CHART...

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Running Head: FDA APPROVAL CHART FDA Approval Chart: Managerial Epidemiology Kaylynn Cash September 27 th , 2019 HA 530 Managerial Epidemiology Paul Okpala
FDA APPROVAL CHART 2 Phase Purpose: Diabetes (Invokana) Anxiety and Panic disorders (Xanax) Subjects: Invokana, Xanax (How many and how selected) Type(s) of Study Design Used: Double Blind placebo Placebo controlled trials Phase I The first studies in animals and humans. The drug alprazolam (Xanax) when tested on humans was shown to have depressant effects of the nonspecific variety on the central nervous system. Xanax tests in animals were conducted in dogs, they also had separate test using rats. Mice were used to complete the trifecta of animals in studies. Invokana also known by its proper drug name canagliflozin when tested on humans was shown in some cases to increase creatinine levels. Invokana when tested on humans showed results that reached past the intended results of lower blood glucose. Canagliflozin was tested on lab mice, rats, and also was tested on other rodents such as gerbils in some case studies For the first run of trials for Xanax the first had a group of 26 male volunteers, all of healthy status were divided up into two groups with one group given a small dosage 0.5mg while the others were given a placebo daily over a two-week span.

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