Question

Which of the following defines phase I research as it relates to non-clinical and other phases of research:

a) Testing on animals
b) Initial human testing
c) Large-scale clinical trials
d) Post-marketing surveillance

Answer 1

Phase I research is the initial human testing of a new drug and focuses on assessing its safety, tolerability, and pharmacokinetic properties to define a safe dosing range.

Step-by-step explanation:

Phase I research refers to initial human testing. This stage of clinical development focuses on investigating the safety and tolerability of a compound in human subjects. During Phase I trials, scientists evaluate the pharmacokinetic properties of the drug, including its absorption and elimination, and establish a safe dosing range. If issues arise such as a too short or too long elimination half-life, or poor bioavailability, the drug may be dropped from further development. This phase usually begins with single sub-therapeutic dose studies which are progressively escalated, followed by multiple dose studies, and closely-monitored to determine if the compound should advance to further development phases.