Massachusetts Pharmacy Technician License Practice Test

What is the primary purpose of the FDA's Phase 2 trials?

1. To ensure drug safety

2. To determine drug effectiveness

3. To evaluate the long-term effects

4. To analyze dosage range

The correct answer is: To determine drug effectiveness

The primary purpose of the FDA's Phase 2 trials is to determine drug effectiveness. During this phase, researchers focus on assessing how well the drug works in people who have the condition the drug is intended to treat. This involves evaluating the therapeutic effect of the drug in a larger group of participants than Phase 1 trials, which primarily focus on safety and dosage. Phase 2 trials are essential for establishing not just that a drug is safe, but that it produces the desired biological response. The results can help determine whether the drug has the potential to be effective enough to move forward to larger Phase 3 trials, which further assess efficacy, as well as monitor adverse reactions in an even broader population. In this context, while ensuring safety, evaluating long-term effects, and analyzing dosage range are important aspects of drug development, the core objective of Phase 2 is to establish the drug's effectiveness in treating the targeted ailment.