Pharmaceutical Phases con't

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21 Mar 2012
3(21) Pharmaceutical Phases
11:00 AM
Phase 5 testing
further trials and monitoring
1 compound approved
Phase 4/5
physicians may be asked/paid by drug company for access to effects and acceptance of drug by
Drug names
Nonproprietary (generic)
Proprietary, trade name, brand name
Health Canada
Link on sakaii
drug action
drug effect
What dose?
Effective dose= ED50
Toxic dose= TD50
Therapeutic index= TI
TI= TD50/ ED50
Black box label
Diabetes drug
Placebo effect
Irving Kirsch
Placebo effects
Numbness 50%
Headaches 25%
Fatigue 18%
Sensation of heaviness 18%
Unable to concentrate 15%
Drowsiness 10%
Nausea 10%
Double blind study
Random study
Crossover study
Advantages and disadvantages
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