Drug Development Revolution

Drug Development Revolution, The development of medicines has 5 fundamental steps that together are designed to guarantee their safety and efficacy. The first factor consists of discovery and development, where researchers are able to discover the way in which a disease behaves and the way in which it affects patients, and the possible substances that could stop, encourage or alleviate the harmful effects of this disease, when a promising treatment is evaluated, researchers undertake experiments to understand the way in which the treatment behaves under different conditions, and how it interacts with other components of the biological system, this is called development.

Subsequently, the step to follow is called pre-clinical research, during this phase, the studies are evaluated in laboratories and in animals to focus on the most promising treatments and the most appropriate application methods for the biological system to determine when they can be supplied safely in people and start the first dosages for clinical treatments and finally establish the best treatment, with the most adequate quantity and supply that is possible. Prior to this step, research organizations must generate a formal application with solid theoretical bases before the FDA, or compatible entities according to the government, in order to have the government’s endorsement prior to the beginning of any clinical practice. The third step is clinical research, which refers to studies about the treatment under development to determine its safety and effectiveness in people. The researchers design clinical treatments that answer the research question, where they are explicitly obeying the government protocol and declaring relevant information about the research so that the regulatory entities verify the transparency of the process carried out, before becoming an investigation to large scale for mass production.

The next step consists of the explicit and public approval of the regulatory governmental entities, which give the endorsement for the creation of clinical patents, based on the benefits and risks of the new treatment to guarantee the safety of potential consumers. Finally, the last step consists of analyzing the results in real patients and monitoring the consequences of the treatment in the population. If the medium and long-term results show deficiencies, collateral problems or low effectiveness, the government entities of the health system may intervene to re-inspect the production activities of the treatment or medicine and may even demand improvements and modifications from the company in charge. From its manufacture, in some cases some medicines have been completely banned due to serious side effects in a high volume of cases. Each of these cases is of vital importance in the direction of guaranteeing the protection of people and implementing the best technologies to develop these medicines.

Written by:

Camila Arango


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