The journey to develop and discover new drugs begins and ends with the patient. Researchers study the role of proteins, which play very vital functions in the body, but sometimes do not operate properly in the case of disease. Once the erring protein or proteins are discovered, a team of researchers is then charged with creating molecules that bind to those proteins to uniquely regulate their function, like flipping a light switch on or off. Researchers use computers and other technologies that allow them to closely see what the protein looks like.
Developing a vaccine takes a lot of time because it must go through several phases before being eligible for use. Drug research is a very long and time-consuming process. This article will describe what a drug is and the five phases of the drug research process.
What is a drug?
A drug can be defined as any substance which can be used to improve our health. These drugs can be used for diagnosis, prevention, treatment, and cure. These drugs alter the pathophysiological state in the condition of the disease. These compounds are called drugs.
Phases of the drug research process
The five steps in the drug research process are together designed to help to ensure that potential new therapies are both safe and effective. These steps are mentioned below:
- Discovery and development. Phase 1 investigates whether the new drug is safe and what its exact effects are on the human body. This is done with a small number of healthy volunteers taking doses of drugs. The drug dosage is increased with time under the supervision of doctors. Regular checks, which often include blood tests, can be used to decide if the drug is safe and effective. It is also called the exploratory phase. Researchers are focused on understanding how a rare disease affects patients and what potential approaches may stop, slow, or reverse the effects of a condition. Once a promising treatment option is found, researchers conduct experiments to find out how therapy may work.
- Preclinical research. In the second phase, the drug’s effectiveness is tested on a small number of patients with the conditions the drug is developed for. It is also tested on a group of healthy volunteers to see whether the drug works safely. But before that, studies are conducted in the laboratory and animals to focus on the most promising treatment candidates and delivery methods, to determine whether they can safely be tested on humans, and to establish an initial dosing level for clinical trials. This phase lays the groundwork for clinical trials that are most likely to bring patients the right drug in the right amount. Before beginning clinical research, drug developers must submit an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA).
- Clinical research. Clinical research refers to studies that involve testing treatments to determine their safety and effectiveness in humans. Researchers conduct clinical trials to elaborate specific research questions, with trials following a study plan known as the protocol. FDA conducts ongoing reviews of the data to check the safety of drugs.
- FDA Review. To start the review of a proposed new therapy, a drug developer submits a New Drug Application (NDA) or a Biologics License Application (BLA) depending on the type of treatment. The FDA review team examines all the data collected and decides whether to approve the drug for the proposed population. These approval committees include independent medical experts and patient representatives.
- Post-market safety monitoring. After the new product is approved and available to the public, the FDA continues to monitor it for any safety issues that might become apparent over time. This ongoing surveillance includes routine inspections of drug manufacturing facilities and programs that allow manufacturers, medical professionals, and consumers to track and report safety concerns about approved drugs. If new safety concerns are detected, the FDA may require changes to the drug label to inform doctors and patients or to remove the drug from the market.
These are the five phases of the drug research and development process, and each step is equally important for the health and safety of people. In addition to drug research, neuropsychological testing is also very important in the drug research process.
David Radar, a psychology graduate from the University of Hertfordshire, has a keen interest in the fields of mental health, wellness, and lifestyle.