In a Human Pharmacology study, which objective is typically included?

• A. Explore use for targeted indication; estimate dosage for subsequent studies; provide basis for confirmatory study design, endpoints, methodologies
• B. Ensure license is granted
• C. Market analysis and pricing strategy
• D. Post-marketing surveillance planning

Answer: (A)

Early human pharmacology studies are about translating preclinical findings into data that guide future clinical development. The best objective is to explore use for a targeted indication, estimate dosage for subsequent studies, and provide the basis for confirmatory study design, endpoints, and methodologies. This combination directly supports deciding whether there is a viable indication, what dose ranges to test next, and how the pivotal trials should be structured to properly evaluate efficacy and safety.

The other options don’t fit this phase of work. Licensing decisions, market analysis and pricing, and post-marketing surveillance planning are handled in regulatory, business, and lifecycle management activities, respectively, and occur outside the core aims of a human pharmacology study.