February, 2003
© 2000, 2001, 2003 Scott S. Emerson, M.D., Ph.D.
When
testing a new treatment or disease preventive regimen, phase III
confirmatory studies are typically preceded by several phase I and
II screening studies
·Phase I:
Initial safety / dose finding
·Phase II:
Preliminary efficacy / further safety
·Phase III:
Establishment of efficacy
·Phase
IV:
-Therapeutics: Post-marketing surveillance
-Prevention:
Effectiveness