If a product is a prescription drug, what testing is mandated before any human studies?

• A. Laboratory animal testing
• B. Immediate human trials
• C. No testing required
• D. Only in silico modeling

Answer: (A)

Before any human studies, laboratory animal testing is required to evaluate a drug’s safety and how it behaves in the body. These preclinical studies look at toxic effects, pharmacokinetics, and pharmacodynamics, helping scientists estimate a safe starting dose for first-in-human trials and identify potential risks to monitor. While computer models and cell-based tests are valuable supporting tools, they cannot replace animal testing to meet regulatory requirements for initiating human research. That’s why the mandated step is laboratory animal testing.