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 condition allowing the drug freedom to operate without competition. If the druggability is not obvious, a 3D-structure for the target protein or a close homologue should be available for assessment. The target should also have favorable ‘assayability’ enabling high throughput screening. To identify these targets there are many strategies that can be utilized such as: genomic analysis (phenotype analysis, genetic association, gene expression profiling, etc.), pathway analysis, and activity-based proteomic profiling (Frank & Hargreaves, 2003; Lipsky & Sharp, 2001; Krishna, Herman, & Wagner, 2008). After conducting extensive animal studies in the laboratory and assessing the safety and biological activity of the drug compound, the
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