Phase 1 Trials Flashcards
1
Q
How do you calculate the maximum recommended starting dose (MRSD)?
A
Find the ‘no-observed-adverse-effect-level’ (NOAEL) from the toxicology studies, and then convert this to the human equivalent dose (HED) based on body surface area. Then divide the lowest HED by a safety factor (usually at least 10) and give the MRSD.
2
Q
Describe the phases of clinical trials
A
Phase 1 = check safety (10-20 healthy volunteers)
Phase 2 = check efficacy (about 200 patients)
Phase 3 = confirm findings in large population, toxicicity
Phase 4 = post-marketing surveillance
