Clinical trials of medicinal products are conducted to evaluate the safety and efficacy of a new drug or treatment. These trials involve several phases of testing, with each phase designed to address different aspects of the drug's safety and effectiveness.
Phase 1 clinical trials typically involve a small number of healthy volunteers and are designed to test the safety and tolerability of a new drug. Phase 2 trials involve a larger group of participants with the disease or condition the drug is intended to treat, and are designed to assess the drug's efficacy and dosage. Phase 3 trials involve an even larger group of participants and are designed to confirm the efficacy of the drug, monitor side effects, and gather additional information on safety and dosage.
After completing these phases, if the drug is deemed safe and effective, it may be submitted for approval to regulatory authorities such as the FDA in the United States or the EMA in Europe. If approved, the drug can be marketed and used by patients. Clinical trials are critical in ensuring that new drugs and treatments are safe and effective for patients.
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