The types and phases of pharmacological clinical trails The pharmaceutical products are manufactured through following certain rules and regulations. After the preparation of pharma solution, it undergoes the series of tests to check their virulence capacity. The pre-clinical trials are done to evaluate the safety and the efficacy of their product drugs. These studies are very important to achieve the regulatory approval by this only the drugs can be made available to the patients. The clinical studies are referred to as the research study that makes involve the human participants to evaluate the effects of drug on the health outcomes. They include the biological products, medical devices and the surgical procedures among others. Types of clinical trails The clinical trials are classified based on the purpose they undergo; Prevention trials This method is to prevent the first time occurrence or the second time reoccurring of the disease. The methods will involve diet and the changing of lifestyle, exercise, vaccines, medical treatment, etc. Screening trials To detect a particular and unknown disease or a condition it is necessary to look for the new ways for identification. Diagnostic trials To detect the particular disease you will have to use new diagnostic machines for the identification process. Treatment trials To combat the illness you will have to test the new surgical, medical, and also the radiation treatment.
The involvement of new drugs is more common in the clinical trials and they are distinguished into four phases. Each phase of drug process will be treated as an individual clinical trial. There are certain stages on the clinical trials start with the pre-clinical research studies and the process moves towards the phase 1, phase2, and phase3. Sometimes the phase 0 studies are carried before the phase1 and the phase 2. Pre-clinical studies Before moving to the clinical process the drug will be undergoing the pre-clinical studies for their toxicity and it is otherwise said to be the ability to cause serious harm as well as the pharmacokinetic information. The dosage will be tested during the pre-clinical research period. Here this trail is carried out both in vitro and in vivo methods as well occasionally with the help of the computer models. Phase 1 After an experimental treatment of drug or pharma solution has been tested on the animal then later it will be tested on the healthy volunteers those who are small in number, they are between 20-80. Purpose of this trial is to identify the metabolic and pharmacological effects of the drug on humans. Phase2 After determined they are reasonably safe the phase 2 trial is carried out to determine the effectiveness of the drug. They are controlled, monitored and tested on a large number of people. Phase 3 At this level, they will be tested in the hundreds or thousands of individuals and they will be monitored for their results. From this trial, they gather the safety and effectiveness and evaluate the overall benefits and risk of the new drug. Final thoughts
After the several phases of trials, the effectiveness of the newly invented drug will be evaluated and it also provides the researchers to learn about the benefits and risks of the drug.