Did you know that, on average, it takes at least 10 years and $2.6 billion to bring a new drug to market?
But it’s not just about inventing a drug and selling it. To ensure the utmost safety and effectiveness, there are several drug development phases required by law before you can list a drug with the FDA.
Whether you’re aspiring to enter the pharmaceutical industry or you’re just interested in the drug discovery process, there are some fascinating steps to learn about.
If you’re intrigued, read on to find out more.
1. Discovery and Development
This is the initial research and development stage; researchers and professionals like CEO Matthew Gline will focus their efforts on treating and curing health conditions.
Companies do extensive research into therapy areas, particularly untreatable diseases trying to find any new biological approach that will help accelerate the pharmaceutical market.
2. Preclinical Research
Once the drug has been conceptualized and designed, it’ll undergo basic testing. This involves laboratory testing In Vitro and In Vivo to determine whether the drug could be toxic. This is where the drug is also tested on animals.
Preclinical research is done on a small scale as an indicator of the drug’s potential.
3. Clinical Research
Clinical research is where the drug is tested on humans in trials. There are three clinical phases, which take up most of the development process.
In phase 1 trials, 20-100 volunteers test the drug for several months. In phase 2, several hundred people will trial the medication for 1-2 years under close supervision. Finally, in phase 3 trials collect epidemiological data of thousands of study participants
4. FDA Review
When all the clinical research is completed, analyzed, and written up, the researchers can make a new drug application to the FDA.
This application must contain:
- Directions for medication use
- Safety and drug abuse potential information
- Patent information
- Labeling details
- Any data collected outside of the United States
- Institutional review board compliance information
Once all this information is submitted, the FDA will review the product and decide whether the drug is safe and effective. If so, they’ll approve the drug to enter the US market.
5. FDA Post-Market Safety Monitoring
Finally, the drug is subject to ongoing monitoring by the FDA. Although trials show initial safety data, things can change – this is why it’s essential to have regular reviews.
The FDA will conduct inspections of manufacturing facilities, check that drug advertising standards aren’t breached, and help regulate any existing patents.
If there are any problems with the drug, the FDA has programs that help manufacturers, healthcare professionals, and patients report any adverse reactions.
The Drug Development Phases Explained
That’s each of the drug development phases explained – did you expect this process to be so in-depth? Even medications like Tylenol that we take for granted now have been through this process.
For more information on the drug discovery process, check out the infographic below!
Infographic provided by OmniAb, an antibody discovery platform research organization
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