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. The products that are used in this study may cure or treat diseases and can be used in surgical procedures. 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 phase also has healthy volunteers. The volunteers are paid in participating in that whole study. The study shows mainly how drugs or devices can react to human beings. The study also shows the side effects that may come up once the product is increased regarding dosage. 65% of experimental drugs are usually tested and must undergo that 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 set of patients usually get the experimental drug while the other set gets the standard experimental 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.
The next phase which is 3, it includes unsystematic and blind testing way in thousands of patient who have volunteered. It can take multiple years, and it gives FDA and pharmaceutical companies to have detailed comprehension of the drug or device. When the product passes through this study phase, it can finalize the requirement that is needed for testing. 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 pharmaceutical companies play a more prominent role in this fourth phase. They compare the older and the new product that has been in the pharmaceutical market that has been into consumption. They also need to monitor the impact and usefulness of the new product into 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 results that come out of this stage entirely determine whether the new pharmaceutical products can be removed from the market or to remain. The fourth stage is always vital in clinical research because it shows the actual results of a new product.