Drug development is a complex process It requires creativity, commitment and extensive research. Each new treatment begins with an initial idea that undergoes a process of incubation, refinement and analysis, first in the laboratory and then in clinical practice over several years.
From initial research to launching a drug on the market It can take between ten and fifteen years. At each stage of the process, there is a significant risk that the compound will not meet the necessary requirements.
Highly specialized medicines are produced in facilities designed for this purpose. These factories are equipped with advanced technology and state-of-the-art air conditioning systems. What is the process that a medicine follows until it reaches the hands of the final consumer? Let’s see.
Discovery and development
The development of a medicine begins with the identification of therapeutic targetswhich are the molecules or proteins associated with a specific disease. Once identified, how these targets influence the disease is investigated and tests are carried out to find compounds that can interact with them effectively.
Target selection
The first step is identify the mechanisms, molecular pathways and associated proteins with the target disease. This stage is essential to select appropriate therapeutic targets.
Compounds that show the potential to become effective medicines are selected for further development.
Molecule design
Once the targets have been identified, Molecules are designed and modified to improve their affinity, efficacy and safety. This initial design is carried out using laboratory techniques and computational models.
Pre-clinical research
Before testing in humans, it is necessary to ensure that the selected compounds are safe. The pre-clinical research stage includes laboratory studies, both “in vitro” (in cells or tissues) and “in vivo” (in living organisms)to evaluate the pharmacology and toxicity of the compound.
The researchers determine safe doses and acceptable toxicity levels. Only if the results are promising does the drug candidate advance to the next phase.
Clinical research
Clinical research is decisive to evaluate how the drug interacts in the human body. Before starting this phase, researchers must submit a detailed report to regulatory authorities, such as the FDA in the United States or the EMA in Europe. This report includes the results of the pre-clinical research and the plan for clinical trials in humans.
Clinical trials are divided into four phases:
- Phase 1. The compound is administered to a small group of volunteers. The safety of the treatment is evaluated and appropriate doses are determined.
- Phase 2. The treatment is tested in a larger group of people to measure its effectiveness and further evaluate safety.
- Phase 3. The drug is tested in large groups of patients to confirm its effectiveness, monitor side effects and compare it with other existing treatments.
- Phase 4. Additional studies are done after the drug is approved to provide information about its long-term use, risks, and benefits.
Registration and authorization
With the results of the clinical trials in hand, the researchers request authorization from regulatory authorities through the submission of the NDA (New Drug Application).
This document includes all the information collected about the medicine, demonstrating its safety, effectiveness and quality. If the authorities approve the NDA, the drug receives authorization to be marketed.
Launch and security monitoring
Once the drug is on the market, its safety continues to be monitored through new clinical trials and data collection. These studies can help identify new indications, improve drug formulation or detect adverse effects not observed in previous phases.
Regulatory Review
- Submission of applications: Once clinical trials are completed, the pharmaceutical company submits an application to regulatory authorities (such as the FDA in the US or the EMA in Europe) to obtain approval of the drug.
- Revision: Authorities evaluate data from clinical trials and decide whether the drug is safe and effective for use in the general population.
Approval and Marketing
- Approval: if the drug meets the safety and effectiveness criteria, receives approval and can go on the market.
- Production: production starts on a large scale of the medicine, guaranteeing that it meets quality standards.
- Marketing: are implemented Strategies to inform professionals of health and patients about the new medicine.
Post-marketing monitoring
- Phase IV: Additional studies are performed after approval to continue monitoring drug safety in the general population and detect rare side effects.
- Pharmacovigilance: authorities and pharmaceutical companies collect patient experience data and can take action if security issues arise.
Constant monitoring ensures the medication remains safe and effective for patients over time.
