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Lecture

Pharmaceutical Phases con't


Department
Science
Course Code
SCIE 1P51
Professor
Caroline Starrs

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3(21) Pharmaceutical Phases
March-21-12
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
patients
Drug names
chemical
Nonproprietary (generic)
Proprietary, trade name, brand name
Health Canada
Link on sakaii
pharmaceuticals
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%
Pharmaceuticals
Double blind study
Random study
Crossover study
Advantages and disadvantages
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