While the usual process followed by the U.S. Food and Drug Administration (FDA)

Question

While the usual process followed by the U.S. Food and Drug Administration (FDA) requires that thorough clinical trials have shown the benefits of a drug before approval is granted, an accelerated approval process is possible in some cases for drugs designed to treat some serious illnesses. Discuss a solution to the problem of addressing patients’ demands to accelerate clinical trials of new medicines while ensuring that the medicines are safe. While the usual process followed by the U.S. Food and Drug Administration (FDA) requires that thorough clinical trials have shown the benefits of a drug before approval is granted, an accelerated approval process is possible in some cases for drugs designed to treat some serious illnesses. Discuss a solution to the problem of addressing patients’ demands to accelerate clinical trials of new medicines while ensuring that the medicines are safe.

Explanation / Answer

Clinical trials are the research studies that are performed during the drug discovery process, they are intended to test the efficiency and side effects of drugs on humans. As the clinical trials of test drugs include humans as the testing subjects, appropriate drug designing is the only possible solution, because the safety measures cannot be compromised. Only the drugs that are completely non-toxic and effective in the pre-clinical trials must be allowed to clinical trials. Using in-silico techniques for drug designing will be more helpful to increase the chances of discovering a safe and effective drug.

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