Basic Concepts in Small Doses
6

Weam Banjar; BDS., MS.
Disclosure
•
•

None
Basic concepts in small doses highlights basic
concepts in research particularly in areas of concerns...
Phases of Clinical Trial

Banjar WM
Phase I
•
•
•
•

New investigational drug
Sample size: small ( ~ 50-100)
Healthy volunteer
Objective: assess safety, deter...
Phase II
•
•
•

Controlled clinical trial
Sample size: several hundreds
Objective: assess effectiveness and further assess...
Phase III
•
•
•

Randomized clinical trial
Sample size: several thousands
Objective: assess effectiveness, monitor side ef...
Phase IV
•
•

Post-marketing surveillance
Collect information on long term effect of marketed drug

Banjar WM
Good Luck

Banjar WM
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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

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Basic concepts in small doses 6 phases of clinical trial

  1. 1. Basic Concepts in Small Doses 6 Weam Banjar; BDS., MS.
  2. 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. 3. Phases of Clinical Trial Banjar WM
  4. 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. 5. Phase II • • • Controlled clinical trial Sample size: several hundreds Objective: assess effectiveness and further assess safety Banjar WM
  6. 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. 7. Phase IV • • Post-marketing surveillance Collect information on long term effect of marketed drug Banjar WM
  8. 8. Good Luck Banjar WM

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