Clinical trial: phases Flashcards
Determines pharmacokinetics and pharmacodynamics and side-effects prior to larger studies
Phase 1
Which phase is used to Assess efficacy + dosage
Phase 2
Who normally partakes in Phase 1 of a clinical trial?
healthy volunteers
Who usually takes part in Phase 2 of a clinical trial
small number of patients affected by particular disease
Which phase of the clinical trial aims to assess effectiveness?
Phase 3
Who is usually involved in phase 3 of a clinical trial?
100-1000’s of patients
often as part of a randomised controlled trial
comparing new treatment with established treatments
What is involved in Phase 4 of clinical trials
Post-marketing surveillance
(for long term side effects and effectiveness)