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Basic concepts in small doses 6 phases of clinical trial

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Brief description of phases of clinical trial

Brief description of phases of clinical trial

Published in: Health & Medicine

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  • 1. Basic Concepts in Small Doses 6 Weam Banjar; BDS., MS.
  • 2. Disclosure • • None Basic concepts in small doses highlights basic concepts in research particularly in areas of concerns for health care professionals Banjar WM
  • 3. Phases of Clinical Trial Banjar WM
  • 4. Phase I • • • • New investigational drug Sample size: small ( ~ 50-100) Healthy volunteer Objective: assess safety, determine safe dose range, identify adverse events Banjar WM
  • 5. Phase II • • • Controlled clinical trial Sample size: several hundreds Objective: assess effectiveness and further assess safety Banjar WM
  • 6. Phase III • • • Randomized clinical trial Sample size: several thousands Objective: assess effectiveness, monitor side effects, compare efficacy to current standard of care Banjar WM
  • 7. Phase IV • • Post-marketing surveillance Collect information on long term effect of marketed drug Banjar WM
  • 8. Good Luck Banjar WM