Which phase focuses on testing in humans?

Which phase focuses on testing in humans?

• A. Discovery
• B. Pre-clinical research
• C. Clinical trials
• D. Post-marketing research

Answer: (C)

Testing in humans occurs during clinical trials. In the drug development process, discovery identifies potential compounds, and preclinical research uses lab and animal studies to gather safety data. Only after those steps can work begin with people, which happens in the clinical trials phase. Clinical trials are typically organized into phases that progressively assess safety, dosing, and effectiveness in humans (Phase I for safety and pharmacokinetics, Phase II for preliminary efficacy and side effects, Phase III for large-scale confirmation of benefit and safety). After a product is approved, post-marketing research (Phase IV) continues to monitor safety in real-world use. So the phase that focuses on testing in humans is clinical trials.

Testing in humans occurs during clinical trials. In the drug development process, discovery identifies potential compounds, and preclinical research uses lab and animal studies to gather safety data. Only after those steps can work begin with people, which happens in the clinical trials phase. Clinical trials are typically organized into phases that progressively assess safety, dosing, and effectiveness in humans (Phase I for safety and pharmacokinetics, Phase II for preliminary efficacy and side effects, Phase III for large-scale confirmation of benefit and safety). After a product is approved, post-marketing research (Phase IV) continues to monitor safety in real-world use. So the phase that focuses on testing in humans is clinical trials.