The Drug Development And Approval Process

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As mentioned in class, as well as in the Krishna (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 should be disease-modifying and/or have a proven function in the pathophysiology of the disease. Target expression should not be uniformly distributed throughout the body. There should also be a favorable IP…show more content…
The main goal in Phase I is to find out if the investigational new drug is safe. In this first phase of human testing, testing determines the correct dosing and exposes the most common side effects. If the investigational new drug is found to be safe, Phase II of human testing can begin. The main goal of Phase II is to find out if the investigational new drug is effective. Unlike in Phase I, the patients tested in Phase II are not healthy. In this phase, testing determines whether the drug works on patients it was designed to help. Results are obtained by comparing the group of test patients to other groups taking a different drug or taking a placebo. Phase III is the first large-scale trial of human testing. This phase can only begin if the new drug shows to be effective in Phase II. Phase III seeks to further determine the effectiveness of the drug. This is done by testing the drug on different populations, meaning that testing will be done on more people, testing will be done with different drug doses, and the drug will be tested on patients who are also taking other drugs. If Phases I through III show the investigational new drug to be safe and effective, then the pharmaceutical company will file a New Drug Application (NDA). The NDA includes both the results of the first three trial phases and data on how the drug is manufactured (Frank & Hargreaves, 2003; Lipsky & Sharp, 2001; Krishna,
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