Before a drug can be approved for pediatric use, it undergoes a series of clinical trials. These trials progress through different phases:
Phase I: Tests the drug on a small group of healthy volunteers or patients to evaluate its safety and determine a safe dosage range. Phase II: Involves a larger group of patients and focuses on the drug's efficacy and side effects. Phase III: Conducted on an even larger group, this phase compares the new drug to existing treatments and collects more information on safety and efficacy. Phase IV: Post-marketing studies that monitor the drug's performance in the general population.
