Wyoming MPJE (Pharmacy Jurisprudence) Practice Exam

What is the primary purpose of Phase 1 in clinical trials?

1. Efficacy, large population with the disease

2. Safety, small healthy population

3. Safety and efficacy, very large population

4. To obtain regulatory approval

The correct answer is: Safety, small healthy population

Phase 1 clinical trials primarily focus on assessing the safety of a new drug or treatment in a small group of healthy volunteers. These trials are designed to evaluate how the drug is processed in the body, its side effects, and the best dosage to use. Once a drug has been shown to be safe in Phase 1, it can then progress to later phases of clinical trials where efficacy and safety in larger populations with the disease are evaluated. Therefore, the correct answer is B. Option A is incorrect because Phase 1 trials do not typically involve a large population with the disease to evaluate efficacy. Option C is incorrect because Phase 1 trials are not conducted in very large populations. Option D is incorrect because Phase 1 trials are not solely conducted to obtain regulatory approval but rather to assess safety.