The study of pharmaceutical products is mainly known as clinical research. Moreover, its well known 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.
In phase one the device and drugs are evaluated for effectiveness and safeness. It consists of healthy volunteers numbering to a hundred. The volunteers are paid in participating in that whole study. The study shows mainly how drugs or devices can react to human beings. It also studies the side effects, in which may occur when the dose is increased in the human body. The pharmaceutical products are mostly tested and need to undergo this first phase.
In phase two the study shows the capability and ability of the products. It can take to almost 2years, and it include more patients. In this group, the volunteers are divided into two groups. The first group of patients get experimental drug and the second group receives the standard 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. the phase helps the FDA to have correct information about the new product.
In phase 3 the unsystematic procedure and blind testing are done to patients who have volunteered. 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.
Post-marketing is the 4 phase, and its conducted mostly after the drug or device has been approved for the consumers to use. The companies have a more significant role in this phase. They need to compare other drugs and the new drugs that have been in the pharmaceutical market. Also, it monitors the effectiveness and the impact of the drug in the patient. 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 phase can be on the device or the drug. The fourth stage is always vital in clinical research because it shows the actual results of a new product.