Drug And Drug Testing In The Roles Of The New Drugs

The United States have to go through a broad review in order to get the approval process by the Unites States Food and Drug Administration before any drugs can be prescribed to any of it patients. By the end of the year 2016, according to the 3.2 billion drugs were ordered from many physician practice for there patients (CDC, 2016). Many of these good and some are harmful drugs have bombarded numerous of pill bottles. Currently, the drugs supposed to go through a process of development, and next approval before being introduce/marketing to patients as well as consumers. However, having a clear outlook at the procedures that should be required to market drugs from the beginning to the end. Also, topics about the testing in†¦show more content†¦The main purpose of clinical trails is to grasp a clear understanding of drugs relation with the human body. First, the drug company would conduct an Investigational New Drugs Process for the review board of the FDA to approve (F DA, 2014). About fifty to one hundred healthy volunteers would study the drug and monitor for any interaction and dosing only if the body can tolerate it, focusing mainly on the side effects. Second, phase two would have sick patients to be studied for many months up to two years or longer to see the therapeutic effects of the drugs (FDA, 2014). Next, phase three which could take one to four years to complete. The huge number of patients, it is crucial because these pivotal trails done by researcher would assist in determine if the new drug can be a viable treatment and benefit to the growing disease population. Now that all the clinical trails are done, the drug company can file a New Drug Application to the FDA for review and approval. Last, the new drug will go to the market. The drug company must still provide the FDA with data, studies, and analyses for the FDA to review the new drug. If the new drug is viewed to be safe by the FDA, the new drug will be approved and advan ce to the next stage of which is labeling (FDA, 2014). For example, a Zantac tablet, known as ranitidine isShow MoreRelatedThe Drug Development And Approval Process1179 Words   |  5 PagesKrishna (2008) article, the drug development and approval process is an extensive and costly endeavor. The goal of experimental medicine is to increase the efficiency of drug development by providing a better understanding of the drug’s mechanism(s) of action, dose response, efficacy, and safety, allowing the process to be accelerated for the most promising and efficacious candidates (Krishna, Herman, Wagner, 2008). Preclinical testing begins with identifying the ideal drug target. The target shouldRead MoreHow Society Is Affected By Drug Usage In Sport?1540 Words   |  7 PagesDrugs have been a problem in our society for years. 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