Clinical Trial: Phases Flashcards
1
Q
Describe Phase 1 of a Trial
A
Determines pharmacokinetics and pharmacodynamics and side-effects prior to larger studies
Conducted on healthy volunteers.
2
Q
Describe Phase 2 of clinical trials
A
They assess dosage + efficacy.It Involvessmallnumber of patients affected by particulardisease
May be subdivided into
- IIa - assesses optimal dosing
- IIb - assesses efficacy
3
Q
Describe Phase 3 of clinical trials
A
It assessing effectiveness.
Typically involves 100-1000’s of people, often as part of a randomised controlled trial, comparing new treatment with established treatments
4
Q
Describe Phase 4 of clinical trials
A
Postmarketing surveillance
Monitors for long-term effectiveness and side-effects.
