Early-phase trials focus on which aspects?

• A. Phase 1: safety and dosage; Phase 2: efficacy and adverse effects
• B. Phase 1: marketing; Phase 2: supply chain
• C. Phase 1: manufacturing; Phase 2: pricing
• D. Phase 1 and Phase 2 occur simultaneously

Answer: (A)

Early-stage trials are about safety and dosing at the first stage, and then about whether the drug works and its adverse effects at the next stage. In Phase 1, researchers mainly determine a safe dose range, tolerability, and basic pharmacokinetics. In Phase 2, the emphasis shifts to assessing efficacy in a larger group and continuing to monitor adverse effects to refine the dose and safety profile. Marketing, supply chain, manufacturing, and pricing belong to commercialization and production considerations that come after these early testing phases. The idea that both phases happen at the same time isn’t how development is typically structured. So the best description is safety and dosage in the first phase, and efficacy and adverse effects in the second.