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How are drugs tested?

U.S. laws and regulations dictate that new drugs must endure many phases of testing to assess their efficacy and safety for use in human subjects. The drug testing process begins with laboratory investigation. During this phase, extensive chemical and animal studies are performed to acquire a better understanding of how the drug works. Following this testing phase, the drug’s safety is assessed in a small group of healthy human volunteers. If all goes well and the drug is deemed safe, its efficacy will be tested on a group of patients who have the targeted condition.

The Third Phase of Medication Testing

If the stringent testing phases noted above are successfully passed, the new drug begins the third phase testing. Advanced clinical trials, or Phase III studies, give the treatment to a large number of afflicted patients to evaluate efficacy, dosage and side effects. If the new drug makes it through Phases I-III, an application is readied and submitted for review by the U.S. FDA. If the FDA deems the drug safe and effective, it receives FDA marketing approval.

The Conclusion of Medication Testing

An Institutional Review Board, or IRB, and the FDA will review the protocol for the clinical research study as it will be conducted by a facility. The IRB is comprised of medical and non-medical professionals of the community who review studies to evaluate the possible benefits and risks, as well as to ensure participants are fully educated on the trial. In essence, the lengthy and rigorous process for drug testing ensures the safety and efficacy of drugs as treatments for human conditions.

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