Clinical trials phases Flashcards
1
Q
How many phases are for clinical trials of new treatments?
A
4
2
Q
what does phase I do?
A
Determines pharmacokinetics and pharmacodynamics
also side effects prior to large studies
3
Q
Who are subjects in Phase I
A
Healthy volunteers
4
Q
what does phase II do?
A
Assess efficacy and dosage
5
Q
who are subjects in phase II?
A
A small number of patients
Can be devided into :
1- IIa for optimum dosing
2- IIb for efficacy
6
Q
what does Phase III do?
A
assess effectivenesss
7
Q
who are subjects of pahse III?
A
100-1000 people randomised to the new treatment or an established treatment
8
Q
What does Phase III, the final phase, do?
A
Postmarketing surveillance
9
Q
what is the purpose of phase III?
A
monitors for long-term effectiveness and side effects
