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Lecture 11

SCIE 1P51 Lecture Notes - Lecture 11: Clinical Trial, Median Toxic Dose, Blind Experiment


Department
Science
Course Code
SCIE 1P51
Professor
Caroline Starrs
Lecture
11

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Lecture 11
Pharmaceuticals/food additives
- Must be tested and evaluated toxicologically in all aspects
- Cumulative 2+2= 4
- Autogenetic 2+ 2 = 3 (reduces efficacy)
- Synergistic 2+2 = 7 (makes stronger)
- Only chemicals judged safe are accepted
Clinical trials
- Why are clinical trials needed?
- Variations among people
- Variation in course of diseases
- Very few “breakthrough” treatments for chronic diseases
- Makes inferences to population who require treatment in the future
Pharmaceuticals
Clinical trial
- A prospective study comparing the effect and value of interventions against a control in human
subjects
- Typical time from synthesis to battle
o 12 years
Phase 1 testing (most clinical trials pay subjects, depending on the treatment)
- 50-80 subjects
- Complete guinea pigs
- Safety
- MTDO maximum tolerable dose
- Pharmacokinetics (how its broken down)
- Healthy subjects or may include subjects with known conditions
- Interaction studies food, other meds
o 1 year
o 5 compounds enter trial
Pharmacokinetics
-study of absorption, distribution, metabolism, and elimination of drugs (ADME)
Absorption
Is it, or not?
Where?
Distribution
Where? Correct place?
Is it, or not?
Metabolism
What’s it broken down into?
Elimination
How?
Phase 2 testing
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- 100-300 subjects who have target illness
- Short term effectiveness
- ED50 (effective dose for 50%)
- 2 years
- 5 compounds enter trial
- Trials use subjects to specifically target disease
Phase 3 testing
1000-3000 subjects
-occasionally mult-centered
-long-term
3 years
3-5 compounds enter trial
Phase 4 testing
- Long term surveillance
- Health Canada/FDA
- Up to 2.5 years
- 1 compound approved
Phase 5 testing
-further trials and monitoring
Phase 4/5
- Physicians may be asked/paid by drug company for access to effects and acceptance of drug by
patient
Drug names
-Chemical
Pharmaceuticals
Effective dose
ED50
(MTO)- Toxic dose
TD50
-therapeutic index (in between D50 and TD50
-T1
= TI = TD50/ED50
Therapeutic window
- Control group study
o Treatment absent
o No active ingredient
Placebo effect
Prozac testing
- Numbness 50%
- Headache 25%
- Fatigue 18%
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