Question

An investigational drug is being tried on health volunteers for its safety and pharmacokinetic properties. Which of the following stages in the drug development process does this scenario most closely describe?

1) Phase I
2) Phase II
3) Phase III
4) Phase IV

Answer 1

Phase I clinical trials involve testing an investigational drug on healthy volunteers to evaluate its safety and pharmacokinetic properties.

Step-by-step explanation:

The scenario you described most closely aligns with Phase I of the drug development process. Phase I clinical trials are the initial stage of testing a new drug in humans, where the main focus is on assessing the safety and tolerability of the drug. In this phase, the investigational drug is administered to a small group of healthy volunteers to determine how the drug is absorbed, distributed, metabolized, and eliminated by the body. Pharmacokinetic properties, such as elimination half-life and bioavailability, are also evaluated in Phase I trials. If the drug is not well tolerated or does not meet the desired pharmacokinetic criteria, it may be dropped from further development.