The process of obtaining a medicine begins with a scientific curiosity aimed at solving health problems. First, scientists begin preclinical testing in the laboratories of pharmaceutical companies or higher education institutions, based on a well-founded hypothesis and a rational method.
Pre-Clinical Phase
In the pre-clinical phase, researchers carry out three main testing stages:
- In Vitro: They test isolated cells or specific tissues.
- In Silico: They use computer simulations to predict how molecules behave.
- In Vivo: They conduct tests on animals, primarily mammals, to assess initial efficacy and safety.
Clinical Tests
Soon after confirming the efficacy in pre-clinical models and validating the initial hypothesis, researchers begin clinical trials on humans, divided into four phases:
- Phase 1: They evaluate the safety of the drug in dozens of healthy volunteers over a few months.
- Phase 2: They check the drug’s effectiveness in dozens to a few hundred individuals with the target disease.
- Phase 3: They test the drug on hundreds to thousands of people. In this most critical phase, they compare the drug with placebos and already established therapies, discarding many drugs based on rigorous risk-benefit assessment.
- Phase 4: After regulatory approval, they commercialize the drug and continue to monitor for potential adverse effects in a larger, more diverse population.
Registration and Commercialization of the Medicine Obtaining Process
Thus, if the drug shows robust safety and efficacy after phase 3, the pharmaceutical industry submits the drug to health surveillance bodies, such as ANVISA in Brazil and the FDA in the United States, to obtain registration. Even after commercialization, phase 4 continues, with the pharmaceutical industry and inspection agencies monitoring possible adverse effects that may arise.
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