Pharmaceutical products must undergo rigorous phases and stages, to ensure they are effective and safe. In diseases such as HIV, cancer, diabetes and more, scientists and researchers are constantly working to help new drugs, and slowly eliminate this disease, but it is all tested before they are made the general public.
It all starts with development. Building system battery will know how the drug is absorbed into the body, the potential benefits of dosage requirements and side effects. This experience has not been tested at this time is only theoretical, and people. That’s what research or scientists believe, but the FDA approved, it has a number of measures and other tires to go before it is considered safe for human consumption and can begin to make a positive difference in the life of the overall picture.
Once the development process is completed, pre-clinical testing of the drug. This step is often carried out in the laboratory using in vitro and in vivo carried out to learn more about this product, get a detailed picture and confirmed is safe for human trials. Doubts about the safety of the product in humans occurs the next stage of clinical trials, entering the stage of human trials.
If the drug is effective bypassing the stage of preclinical research, when he went to the stage of clinical research, which consists of four phases to determine whether the products are safe, how effective it is, to learn more about the side effects, risks and benefits.
First, a pharmaceutical company or business experts are beginning to engage participants in the study. These include factors such as age, sex, medical history, health, and much more. You can also see how many participants that they must ensure that they were charging a clear picture of the product by the FDA. Participants 4-50 participants may vary, several hundred participants.
Dosage and evaluation will be determined later, the clinical trial. A phase usually takes a few months, usually focused on the aspects of a security product with only seventy percent of medicines to the second stage. Scene last 2-2 years, depending on whether they are concentrated in this success. On the efficacy of the product is only approximately thirty percent of the product makes it possible for the three phases of clinical trials.
The third phase is a long process, which can go up to four years. In this aspect of the larger size of the drug with the participants, followed closely monitored and tested. It determines all product benefits and side effects. Everything must be recorded in detail and will be submitted to the FDA for approval.
Only thirty percent of pharmaceuticals for the fourth and final stage. After the completion of the fourth phase, which is collected and documents provided to improve the quality of life and made the difference in the world to the FDA for review by the general public.