February, 2003
© 2000, 2001, 2003 Scott S. Emerson, M.D., Ph.D.
Phase I: Initial
safety / dose finding in humans
Goals:
·Pharmacokinetics
/ pharmacodynamics
·Incidence of
major adverse effects
·Decide
whether it is ethical to continue testing in humans
Methods
·Relatively
small number of participants
·Participants
often not true target population
·Sometimes
dose escalation
·Sometimes no
comparison group