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NBME 22 Answers

nbme22/Block 2/Question#17

Ten healthy human subjects are given a new oral ...

Phase 1

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FA2019 p256 "SWIM"

  • 1 - small, healthy group or volunteers w/ disease- Is it S afe
  • 2 - moderate-sized group w/ disease - Does it W ork
  • 3 - large group w/ disease/RCT - Is it an I mprovement compared to currently available treatment
  • 4 - Surveillance after approval - Can it stay on the M arket?

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submitted by armymed88(15),

Phase 1- small # of healthy people. Is the drug safe? Phase 2- smell # with disease. Does it work? Phase 3- large #, some with new drug, some with old. Is is good or better? Phase 4- Postmarket watch. Can it stay?