The Drug Development Process with UPM Pharmaceuticals

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.