Phase I Trials Flashcards
1
Q
What are the phases of clinical drug development?
A
Pre-clinical Phase I Phase II Phase III New drug application Marketing authorisation Phase IV
2
Q
Phase 1 and 2 are part of early drug development.
What does this involve?
A
Tests safety, tolerability, pharmacokinetics, pharmacodynamics, dose response, proof of concept…
3
Q
What is meant by a SAD trial?
A
Single ascending dose
4
Q
What is meant by a MAD trial?
A
Multiple ascending dose
5
Q
Why might healthy subjects be used instead of patients?
Why might this be a problem?
A
Plentiful
Compliant
More robust
Not on treatment
Can be a problem extrapolating to patients
6
Q
How is the maximum recommended starting dose calculated?
A
Find the no-observed-adverse-effect level in toxicology studies
Convert each NOAEL to human equivalent dose based on body surface area
Divide lowest HED by safety factor (usually at least 10)
