Clinical Trial: Phases Flashcards
1
Q
What are the goals of phase 1 of trials?
A
- Determine
- Pharmacokinetics
- Pharmacodymanics
- Side effects
2
Q
Who are phase 1 trials conducted on?
A
Healthy volunteers
3
Q
What is the goal of phase 2 trials?
A
- Assess Efficacy & Dosage
4
Q
Phase 2 trials can be subdivided into IIa and IIb trials. What are these trials?
A
- IIa - assesses optimal dosing
- IIb - assesses efficacy
5
Q
In a phase 2 trial what sample of people are used?
A
A small number of patients that are affected by a particular disease.
6
Q
What is the goal of a phase 3 trial?
A
- Assess effectiveness
7
Q
What type of trial type is used in a stage 3 trial?
A
A randomized control trial
8
Q
What is the goal of phase 4 of a clinical trial?
A
Postmarket surveillance.
Monitors for long-term effectiveness and side effects.
