What are the Four Phases of Drug Development? | More than 20,000 prescription drug products are approved for marketing, with new ones being created all the time. Getting one approved might seem easier than it really is based on that statistic by the FDA, but the reality is, developing a new medicine is a massive undertaking.
There’s a rigorous process that Adare Pharmaceuticals and all other drug companies must go through for potential medications to get approval for use. In fact, most take around a decade from the initial formulation to FDA approval to make it to your local pharmacy.
There are four key phases of drug development that cover everything required to get a drug onto the market.
Phase one is a discovery and development phase where researchers look at the potential of the medication by testing molecular compounds. After the experts have identified potential compounds for their experiments, drug development can occur. There will be studies conducted on the methods used to administer the medication, determine appropriate dosage, how it’s absorbed and metabolized, possible interactions with other drugs, potential side effects, and how those side effects may vary depending on demographics.
Before clinical research can be done, preliminary research, referred to as the preclinical research phase, must be conducted. Now that researchers have looked at the possibilities for a new drug, they need to determine if there is potential for toxicity. It can be conducted as in vivo or in vitro research, with the latter referring to experimentation within a controlled environment outside of a living organism. The former means that it will occur in a living organism.
Both in vivo and in vitro must follow strictly regulated lab practices that outline the requirements for equipment, facilities, researchers, and more. While they’re usually smaller than clinical trials, there must be evidence provided in detail that’s related to toxicity levels and the appropriate dosage. If it’s found that the drug is safe for testing in humans, it will move to the next phase.
When a pharmaceutical drug is ready for human testing, the third phase can begin. This is when clinical research takes place to determine how an individual’s body will react to the medication. Planning this research can take a lot of time and effort, figuring out how many will participate, the duration of testing, and the various types of assessments, with each element required to meet strict FDA standards.
There are sub-phases that must occur within this phase as well. Initially, 100 or fewer study participants are usually involved with the study, which lasts for a few months to determine dosage and safety. The next involves as many as several hundred participants who must have the condition that the drug is aiming to treat. It can last as long as two years, with this period used to note any side effects and the drug’s efficacy.
The third subphase may involve up to 3,000 participants and have a duration of up to four years. During this time, longer-term adverse reactions will be explored while efficacy continues to be monitored. Just one-quarter to one-third of these drugs will move forward to the final phase, which involves thousands of people who’ve been diagnosed with the condition. The efficacy and safety of the medication will continue to be monitored, and if it passes, the FDA will then review it.
The final phase is FDA review, which requires a developer to submit a new drug application to the FDA that includes all of their findings from the first three phases. The FDA has up to 10 months to complete the review. If it’s approved, the agency will continue to monitor its safety.