Sunday, February 2, 2020
Drug Development and Toxicology Essay Example | Topics and Well Written Essays - 1000 words
Drug Development and Toxicology - Essay Example The Food and Drug Administration (FDA) reports that most of the drugs reported to it do not come with sufficient information. The FDA says that drug developing companies need to submit information on the compounds that are used to manufacture the drug, uses of the drug and its effects among other important data. It reports that if companies submitted this kind of information, the drug approval process would be much quicker than the current 8 years that are required. Consequently, it would increase the number of drugs that are clinically approved to enter the market without any restrictions (Friedhoff, 2009). In the end, this will help save a lot of money as well as patients who die in during the approval period. One common reason for the failed approvals is that drug development companies fail to indicate the optimal dosage that a patient should use so as to minimize the listed drug effects as well as any dangers associated with taking the drug. When undergoing the approval process, such a drug will be disqualified from the clinics conducting the trials have no way of knowing the appropriate dosage. FDA also noted that the populations that are sampled during drug development are very different from the population that is meant to use the drug (Zanders, 2011). When clinical trials are being conducted and such an error is noted, the drug is disqualified as having been developed for a different population from the one that its safety tests were conducted on (Friedhoff, 2009).
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