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Clinical Trial Drugs Regulations and Manufacture - Thesis Example
Finance & Accounting
Pages 42 (10542 words)
Clinical trial drugs regulations and manufacture. Clinical trials are of great importance for many common reasons. …
For instance if one treatment is effective in children, could if be equally as effective with adults. Trials confirm what treatments are being used safely and satisfactorily on individuals. There importance is limitless amongst the population of the medical world. For quite some time, clinical trials in the pharmaceutical industry have been regulated by several government bodies. These regulations are set forth by entities like the United States Food and Drug Administration (FDA), the European Medicines Agency (EMEA or EMA), the International Conference on Harmonization (ICH), and the Medicines and Healthcare products Regulatory Agency (MHRA), to name a few. These entities weigh a heavy collateral on how pharmaceutical companies transition medicines from ideal to market with the use of clinical drug trials. The severity of the clinical trial drugs process has a significant donation to the well being of humanity, but faults in production of medications that will suffice in the treatment of those it was produced to treat. James Bryce once said; “Medicine, the only profession that labors incessantly to destroy the reason for its existence”. In short drug trials are performed to adhere to safety regulations that conform to human health strategies. According to the United States National Institutes of Health Service clinical trials are “considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol” (Understanding Clinical Trials, 2007). In order to associate the importance of these trials, it has to be first comprehended as to where they have evolved from. Traditionally, clinical drug trials can be associated with pharmaceutical medicine. ...
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