drug development trials Flashcards
1
Q
how many phases are there of a drug trial
A
4
2
Q
what is phase 1
A
small study size ( 100)
healthy volunteers
examines pharmacodynamics + pharmacokinetics
3
Q
phase 2
A
small study size ( 100-300)
actual patients
efficacy and adverse effects
4
Q
phase 3
A
larger study ( 500-5000)
efficacy, adverse effects
comparisons to existing treatments
special groups : renal impairment and elderly
5
Q
phase 4
A
post-marketing surveillance
6
Q
A
