South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Phase I clinical testing primarily assesses what aspect of a drug?

1. Cost-effectiveness

2. Drug properties and safety

3. Long-term efficacy

4. Patient satisfaction

The correct answer is: Drug properties and safety

Phase I clinical testing primarily focuses on evaluating the drug properties and safety of a new medication. During this phase, the primary goal is to determine how the drug behaves in the human body, including its pharmacokinetics (how the drug is absorbed, distributed, metabolized, and excreted) and pharmacodynamics (the effects of the drug on the body). In Phase I trials, a small group of healthy volunteers typically participates, allowing researchers to identify any potential adverse effects or toxicities associated with the drug at various dose levels. This information is critical for establishing safe dosage ranges before advancing to larger groups in subsequent phases, where efficacy and overall effectiveness are more rigorously evaluated. In summary, the emphasis in Phase I is on establishing foundational safety profiles and understanding basic drug characteristics, making the assessment of drug properties and safety the primary focus of this initial clinical testing phase.