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Clinical Research for Pharmaceutical Products

The term used for the study of pharmaceutical products is known as clinical research. The study mainly takes part as a branch in the study of health science. Products that are used can cure and relieve diseases and also may be used in the surgical section of the study. So at this study, ones the drugs have been approved by FDA they continue into other phases.

In phase one the device and drugs are evaluated for effectiveness and safeness. 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. It mainly shows how the pharmaceutical drugs and device react to the patients. 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. The study can almost take up to 2years, and it includes many patients. The patients are divided into two groups. The first groups get the experimental drug while the other set of patients get the standard experimental drug treatment. The phase has firm procedures whereby both the investigator and patients don’t know which type of experimental drug has been used in each group. This helps the FDA to have the correct details about the new drug.

In phase three it includes blind testing and unsystematic way into thousands of patients. The phase takes a longer period so that the pharmaceutical companies can get the correct details and information about the product. After the drug pass through this stage, they are most likely be able to finish the requirement needed in testing at this phase. After the completion of this phase the companies requests FDA to approve the device or drug for marketing.

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 usually take a more significant part in this last 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. They need also to determine the cost-effectiveness and the drug therapy that was before the new drug that was approved. The results that come out of this stage entirely determine whether the new pharmaceutical products can be removed from the market or to remain. The result that are found in the fourth studies can either make the device or drug to be taken out of the pharmaceutical market, this fourth phase is the most important and vital in the study of clinical research.

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