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Scope Study of Clinical Research

The study of pharmaceutical products is mainly known as clinical research. The study mainly takes part as a branch in the study of health science. The products that are used in this study may cure or treat diseases and can be used in surgical procedures. When the drugs are approved by FDA, they are set to be studied in other phases.

At phase one it mainly the evaluation and safeness of the devices and drugs. The main period can usually take months, and it may have healthy volunteers of 30 to 100. Each volunteer is paid for taking part in the study, and it may take a long period of up to several months. The study is to show how the drugs or devices react to human metabolism. Also, it shows the side effects that can occur once the dosage is increased. The pharmaceutical products are mostly tested and need to undergo this first phase.

The ability of both the device and drug are shown in phase two. It can take to almost 2years, and it include more patients. The patients in this phase are divided into two groups. The first groups get the experimental drug while the other set of patients get the standard experimental drug treatment. Patients and investigators are blinded so that neither of them know which group is has acquired the experimental drug. The tactic is used so that the investigators can give precise details to the FDA, about the new drug.

In phase three it includes blind testing and unsystematic way into thousands of patients. Under this phase, it’s usually long and can take a more extended period for the pharmaceutical companies to have detail information about the device or drug. When the product passes through this study phase, it can finalize the requirement that is needed for testing. When the completion of the third phase is done, the companies can request for the approval of the device or drug in the medicine market.

The last and most crucial phase is the fourth one and it’s known as post-marketing, and its mostly done once the product has been approved by FDA for the use or consumption by consumers. The companies have a more significant role in this phase. They compare the older and the new product that has been in the pharmaceutical market that has been into consumption. The monitoring of the new product on the impact, and its effectiveness into the consumers. The cost-effectiveness is also done at this stage, and it consists of the older drug therapy and the new drug therapy that has been approved by FDA. The results that come out of this stage entirely determine whether the new pharmaceutical products can be removed from the market or to remain. This phase is the most important in the clinical research since its show the correct and actual results of the new product that has been introduced in the market.

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