The Process of Drug Discovery & Development
Understanding the process of drug discovery and development is crucial in comprehending the lengthy journey from the laboratory to the local pharmacy. This extensive process, spanning years or even decades, is vital to the creation of effective medication. The complex process involves discovery stages, preclinical research, clinical trials, and FDA review, each of which carries its respective level of importance and precautionary measures.
Discovery Stages
The journey to a new medicinal drug begins with the identification of a disease or medical condition that necessitates a cure. Scientists carry out exhaustive research to understand how the illness functions at a molecular level. Understanding the condition helps researchers identify certain ‘targets,’ which are usually proteins or larger biochemical pathways that can be modified to cure or mitigate the condition. Often, these discoveries are made through technological advancements, such as genomics.
After identifying targets and their possible modifications, scientists create a ‘prototype’ drug called a lead compound. Lead compounds are either identified through laboratory tests or drawn from a bank of substances known to affect certain targets. More often than not, several lead compounds are identified, leading to rigorous testing to decide which is most effective and safest for further development.
Preclinical Research
Scientists must conduct preclinical research before advancing to the human testing phase. The preclinical research phase involves both in vitro (laboratory experiments including cells and proteins) and in vivo (experiments using whole, living organisms) testing. Researchers will typically administer the potential drug to animals first to observe the drug’s effects on biological systems and evaluate its safety profile.
Extensive toxicology studies are also conducted during this phase to understand the drug’s interactions with living systems and identify any potential short-term and long-term side effects. If the preclinical research demonstrates that a drug can potentially treat a disease or condition safely, the developers lodge an application with the U.S. Food and Drug Administration (FDA) to start clinical testing.
Clinical Trials
Clinical trials entail three phases and represent the most substantive part of the drug development process in terms of both time and capital investment. These trials are carried out under strict regulations to ensure safety and ethical standards are met.
Phase one involves testing the drug on a small group of healthy volunteers. This stage tests its overall safety, dosage range and side effects. In phase two, the drug is given to a larger group of people, this time suffering from the disease or condition. This phase examines the drug’s efficacy and the short-term side effects. If stage two is successful, the drug is tested in phase three, usually on thousands of patients in hospitals and clinics. This phase verifies the efficacy of the drug and monitors its effects in different populations and different combinations with other drugs.
FDA Review
Once all three phases of the clinical trials are completed successfully, the pharmaceutical company applies for a New Drug Application (NDA) with the FDA. The FDA’s review process is rigorous; they scrutinize every stage of the drug’s development, from the chemical makeup and manufacturing quality to its labeling and proposed uses. Once approved, the drug can be marketed to the public.
Conclusion
While the process of drug discovery and development often takes years, even decades to complete, it is a necessary pathway in creating effective and safe medication. The stringent steps, from initial discovery through preclinical research and clinical trials to FDA approval, ensure patient safety and the drug’s effectiveness in treating conditions.
FAQs
- Why does drug discovery and development take so long?
It takes a long time due to the rigorous testing stages: from initial discovery, preclinical tests and clinical trials, to the time taken by the FDA for approval. Each of these steps can take several years.
- What happens if a drug fails at any stage?
If a drug fails at any stage of development, it is usually discarded. However, the gathered data can still be useful for adjusting the drug or making other discoveries.
- How are clinical trials conducted ethically?
Clinical trials are conducted under strict ethical guidelines, including informed consent from all participants. Studies are also monitored by an independent committee to ensure safety.
- What occurs after FDA approval?
Post-approval, the FDA continues to monitor the drug for any post-market safety issues. Also, the pharmaceutical company starts selling the drug to the public.
- Can a drug be withdrawn after approval?
In rare cases where safety issues arise post-approval that were not detected during clinical trials, the FDA has the authority to withdraw approval and remove the drug from the market.
