The Drug Development Process | US Based Drug Manufacturer
A Closer Look at the Drug Development Phases Involved in Getting a Pharmaceutical to Market
In order to introduce top-quality drugs to the market, the process of pharmaceutical formulation must be thorough and extensive. On average, the drug development process takes at least ten years. What goes on throughout that time of drug product development?
1. Discovery and Development
As the first phase of drug development, this period consists of research and innovation in the laboratory. Researchers may discover new drugs by testing molecular compounds for their beneficial effects, using new technologies on the market and examining existing treatments that have unanticipated effects. After researchers have identified a compound with potential, they begin to conduct experiments. The drug is tested to gather information on a number of things from the best dosage and potential benefits it provides to how it affects different groups of people.
2. Preclinical Research
Before a drug can be administered to the public, it must be tested to determine if it has the potential to cause harm. The preclinical research phase involves laboratory and animal testing to help conclude the drug's safety. Studies must provide thorough information regarding drug dosing and toxicity levels. When preclinical testing ends, researchers must examine their findings to conclude whether the new drug should be tested on people.
3. Clinical Research
While lab and animal testing help determine basic information regarding a drug's safety, they can only go so far. Clinical research involves the testing of new drugs on people to make sure they're safe and effective. A variety of clinical trials are conducted on people suffering from the condition the drug is intended to treat. Results are recorded and submitted to the Food and Drug Administration (FDA.)
4. FDA Review
If clinical and preclinical research concludes a drug is safe and effective, a drug developer can file an application to market the drug. When this occurs, the FDA must examine all data submitted regarding the drug and decide whether or not to approve it. If the drug is approved, the FDA will work with the applicant to refine prescribing information.
5. FDA Post-Market Safety Monitoring
During this final phase of drug development, the FDA monitors the drug product's safety public. While clinical trials provide insight regarding a drug's safety, this phase helps provide the true picture of how a product performs in the marketplace. The FDA will review problems regarding the drug and has the power to add cautions to the dosage or usage information and take other measures for more serious issues if necessary.
Our Pharmaceutical Formulation Services
As an award-winning CDMO, UPM Pharmaceuticals is proud to specialize in drug product development. From commercial manufacturing to packaging and warehousing, we offer extensive services to assist you throughout the pharmaceutical phases from start to finish. With the commercial pedigree of 80 products brought to market, our team is highly qualified to handle the demands of your project. Our large manufacturing facility, warehouse and pharmaceutical campus are equipped with essential tools and resources for the drug development process. From pharma formulation to packaging, UPM Pharmaceuticals can do it all!
Get Drug Product Development Services with UPM Pharmaceuticals
Ready to dive into the drug development process and get started on your pharma formulation? Look no further than UPM Pharmaceuticals! We're dedicated to bringing exceptional products to the market throughout all phases of the manufacturing and packaging process. To get started, contact us online today or call +1 423-989-8000.Contact Us