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

20 views5 pages
Published on 15 Apr 2013
School
Brock University
Department
Science
Course
SCIE 1P51
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
Unlock document

This preview shows pages 1-2 of the document.
Unlock all 5 pages and 3 million more documents.

Already have an account? Log in
- 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%
Unlock document

This preview shows pages 1-2 of the document.
Unlock all 5 pages and 3 million more documents.

Already have an account? Log in

Document Summary

Must be tested and evaluated toxicologically in all aspects. Autogenetic 2+ 2 = 3 (reduces efficacy) Very few breakthrough treatments for chronic diseases. Makes inferences to population who require treatment in the future. A prospective study comparing the effect and value of interventions against a control in human subjects. Typical time from synthesis to battle: 12 years. Phase 1 testing (most clinical trials pay subjects, depending on the treatment) Healthy subjects or may include subjects with known conditions. Interaction studies food, other meds: 1 year, 5 compounds enter trial. Study of absorption, distribution, metabolism, and elimination of drugs (adme) Physicians may be asked/paid by drug company for access to effects and acceptance of drug by patient. Control group study: treatment absent, no active ingredient. Patient does not know if the control group or treatment group. Neither patient nor-researcher knows who is in the control group or treatment group. Positive control (test new against old) (no placebo)

Get OneClass Grade+

Unlimited access to all notes and study guides.

YearlyMost Popular
75% OFF
$9.98/m
Monthly
$39.98/m
Single doc
$39.98

or

You will be charged $119.76 upfront and auto renewed at the end of each cycle. You may cancel anytime under Payment Settings. For more information, see our Terms and Privacy.
Payments are encrypted using 256-bit SSL. Powered by Stripe.