A New Pharmaceutical Has Been Approved

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The process of bringing a new drug to market is typically lengthy and involves several steps. As a result, the procedure may take a long time to complete, and even then, only a tiny percentage of pharmaceuticals produced can pass the examination. The Food and Drug Administration (FDA) is in charge of approving products in the country. Before being approved, manufactured pharmaceuticals must pass both pre-clinical and clinical tests.
Pre-clinical Evaluations
This starts with laboratory examinations, which they must pass to analyze the drug’s dose’s critical details. For pre-clinical research, living tissues and animals are used in the laboratory. At this stage, data concerning the safety of the drugs are collected. Another critical goal for carrying out the preclinical study is for coming up with the dose that will be safe to use on humans in the subsequent stages. Therefore, it is vital to collect accurate information in order to commence safe trials on humans (Lipsky & Sharp, 2001).

Clinical Trials

In clinical trials, the researchers carry out studies on volunteer human beings with the main aim of examining the safety and efficiency of the pharmaceutical under study. Clinical trials aim to find out if the drug is safe or harmful to humans. It also examines their effectiveness compared to the existing ones. Clinical trials comprise of three phases.

Phase 1: The main aim here is to find out the maximum possible dosage that is advisable to a patient before undesirable outcomes become unbearable (Gad, 2009). The study recruits a small sample size of less than 100 individuals.

Phase 2: it studies whether the drug has any biological effect. This phase also continues to assess the safety of the drug and determine how effective the drugs are. The sample size in this phase is usually between 100-300 human volunteers (Gad, 2009).

Phase 3: the main purpose is to determine the value that this new intervention will add to the existing clinical practice. The sample size is 300 to 3000 people. In this phase as well, the pharmaceutical in question is tested against the current treatment (Gad, 2009). Phase 3 trials usually last longer due to the large sample size involved.

The process of approval and introduction of new pharmaceuticals to the market is usually lengthy and costly. The process may take as long as 12 years between the time of discovery and introduction to the market (Lipsky & Sharp, 2001). Several stages are involved in the testing of the pharmaceuticals making the process lengthy. The process is equally expensive. Before the introduction to the market, the manufacturing company may spend nearly $2 billion (Lipsky & Sharp, 2001). Yet still, the success is not a guarantee.

Before the commencing of any trial, the manufacturer must seek an approval from the FDA. The FDA examines results from the pre-clinical trials keenly to establish the possibility of carrying out the test on humans. FDA consists of a board of scientists, who are responsible for supervising the trial process of a new pharmaceutical. They also offer advice to the manufacturing company concerning the type of individuals to use for the test trials and the laid out procedure (Institute of Medicine and National Research Council, 2005).

References

Gad, S.C. (2009). Clinical Trials Handbook. Hoboken, NJ: John Wiley & Sons.

Institute of Medicine and National Research Council. (2005). Federal Agency Roles in Cancer Drug Development from Preclinical Research to New Drug Approval. ‎Washington, DC: National Academies Press.

Lipsky, M.S., & Sharp L.K. (2001). From Idea To Market: The Drug Approval Process. The Journal of the American Board of Family Practice, 14(5), 362-367

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