New Pharmaceuticals

The medicines, drugs, or vaccines that are manufactured by the pharmaceutical companies are not just developed and floated in the market overnight. In fact, they usually come out in the market after several years of idea or formula development of a particular drug. It is because they have to pass through several stages to reach the final users; therefore, the paper would discuss the major steps and processes that are required by the companies to bring the medicine to the market.

Certain steps of moving developing and moving a drug into the market include developing a drug, conducting preclinical studies, clinical trials that include several phases, new drug application, and post approval research and marketing. First of all, the companies spend millions of dollars for the development of a drug through research and development done by experts, doctors, and scientists, keeping in consideration the need of a specific drug that must be developed to counteract with the upcoming new diseases.

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Secondly, preclinical studies are conducted that aim to determine the level of synthesis and purification in the drug. In this phase synthesis is done on the new drug by testing them on the animals in order to test the “therapeutic potential and pharmacological activity”; moreover, they are also tested on “tissue samples, enzymes, cloned receptor sites and computer modules” (obesity101. com, 2009). Harmful biological elements that might be present in the drug are identified and removed.

Third step is conducting of Clinical Trials that has three phases in itself. These trials revolve around the testing of drugs over human beings. The first phase aims to analyze the safety and pharmacology in the drug over small number of people who are healthy and participate in the testing process by their own free will. This is done to identify whether the drug has any side effect or not. Second phase is conducted over patients in order to identify the ‘effectiveness’ of the drug, whether it gives the outcomes which it is designed for.

And finally, phase three is directed to test the drug over greater number of patients who volunteer; this is done to ratify the results gathered from phase 2 (Lipsky & Sharp, 2001). After clinical trials, a new drug application (NDA) is written to the Food and Drug Administration (FDA), which includes all the relevant information about preclinical and clinical testing, manufacturing process used by the company, level of toxicity in the drug, ingredients, and labeling.

FDA reviews the whole information deeply and propose recommendations that might include the inclusion or exclusion of certain elements, ingredients, or removal of deficiency that might be present in the drug. Nevertheless, FDA often approves the drug at least on a temporary basis. The last stage is of Post approval research studies that are conducted to abide by the recommendations of FDA and other health-related rules, laws, and regulations when it comes to the production and labeling of drugs.

Moreover, marketing of those drugs or medicines should also be done in an effective way that does not include the hiding of any information, deception, lying, or any other tactics that may harm the consumers. References Lipsky. M. S & Sharp. L. K. (2001). From Idea to Market: The Drug Approval Process. Jabfp. September-October 2001. Volume 14. No. 5 Obesity101. (2010). Bringing a new drug to market. Retrieved on July 27, 2010. From http://www. obesity101. com/drugdev. htm

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