Drug development is a complex process It requires creativity, commitment and in-depth 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 This can take between ten and fifteen years. At every step of the process, there is a significant risk that the compound will not meet the necessary requirements.
Highly specialized medicines are produced in purpose-built facilities. These factories are equipped with advanced technology and state-of-the-art air conditioning systems. What is the process a medicine goes through until it reaches the hands of the end consumer? Let’s see.
Discovery and development
The development of a drug begins with the identification of therapeutic targetswhich are the molecules or proteins associated with a specific disease. Once identified, how these targets influence disease is studied and tests are carried out to find compounds that can effectively interact with them.
Target selection
The first step is identify mechanisms, molecular pathways and associated proteins with the target disease. This step is essential to select appropriate therapeutic targets.
Compounds that show the potential to become effective drugs are selected for further development.
Molecule design
Once the targets have been identified, Molecules are designed and modified to improve their affinity, effectiveness and safety. This initial design is carried out using laboratory techniques and computer models.
Preclinical research
Before testing on humans, it is necessary to ensure that the selected compounds are safe. The preclinical research phase 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 move on to the next phase.
Clinical research
Clinical research is instrumental in evaluating 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 preclinical research results and clinical trial plan 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 assessed and appropriate doses are determined.
- Phase 2. The treatment is being tested on a larger group of people to measure its effectiveness and further evaluate its safety.
- Phase 3. The drug is being 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
Based on the results of the clinical trials, the researchers are requesting authorization from regulatory authorities via 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 marketing authorization.
Launch and Safety Monitoring
Once the drug is placed on the market, its safety continues to be monitored through further clinical trials and data collection. These studies can make it possible to identify new indications, improve the formulation of drugs or detect undesirable effects not observed during previous phases.
Regulatory review
- Submission of applications: After the clinical trials are completed, the pharmaceutical company submits an application to regulatory authorities (such as the FDA in the United States or the EMA in Europe) to obtain approval of the drug.
- Revision: Authorities evaluate clinical trial data and decide whether the drug is safe and effective for use in the general population.
Approval and commercialization
- Approval: if the medicine meets the safety and effectiveness criteria, receives approval and can be placed on the market.
- Production: production starts large scale of the medicine, ensuring that it meets quality standards.
- Marketing: are implemented Strategies for informing professionals health and patients on new medicine.
Post-market surveillance
- Phase IV: Additional studies are carried out after approval of continue to monitor drug safety in the general population and detect rare side effects.
- Pharmacovigilance: authorities and pharmaceutical laboratories collect patient experience data and can take action if security issues arise.
Constant monitoring ensures the safety of the medicine and effective for patients over time.
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