Established and defined by the US Food and Drug Administration (US-FDA), drug development includes the five stages below:
- Discovery and Development
- Preclinical Research
- Clinical Research
- FDA Review
- FDA Post-Market and Safety Monitoring
Discovery and Development: In this step, researchers in academic institutions, government laboratories, and pharmaceutical companies' Research and Development discover new pharmaceutical drugs and formulations. In this step, the pharmaceutical development purpose is to stop or reverse the effect of a specific disease or illness. In these steps, experiments are designed with various biomolecules to identify the benefits of a particular formulation that works for a disease or condition. Moreover, the unanticipated effect of those formulations is recognized for any adverse effects on patients. Lastly, the new technologies are incorporated with lipid nanoparticles to target a specific site of interested tissue, cell, or organ.
While thousands of formulas are being studied at the discovery stage of the development, only a few candidates with promising in-vitro results are taken for further investigations. Upon further investigations, the formulation will be identified with final specifications to be the drug candidate.
Furthermore, there are additional optimizations to identify several parameters and drug attributes such as absorbance, drug distribution within the body, metabolism, and exertion. Another critical parameter is administering the pharmaceutics into the body and finding the most optimized way of doing it. Other parameters are dosage, side effects, toxicity, interaction with other drugs and pharmaceutics, and the competitive advantage to different but similar formulations studied and optimized in this stage.
We will cover stage 2-5 in the following later articles.
Commissioner, Office of the. U.S. Food and Drug Administration, FDA, www.fda.gov/.