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Lecture

Pharmaceutical Protocols


Department
Science
Course Code
SCIE 1P51
Professor
Caroline Starrs

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3(19) Pharmaceutical Protocols
March-19-12
10:52 AM
Mutagenicity
-carcinogenic
-90 days
-3 dose levels
-Ames test
-Salmonella
-reproduce
-chromosome changes
Pharmaceuticals/food additives
-teratogenicity
-teratogen: mis-read DNA
-fertilization
-birth defects
-must be tested and evaluated toxicologically in all aspects
-cumulative 2+2=4
-antagonistic 2+2=3
-synergistic 2+2=7
-only chemicals judged safe are accepted
Teratogenicity
-birth defects
-2 species, 3 generations, 2 litters per generation
-treated for 60 days prior to gestation an throughout pregnancy and weaning of offspring
Long term toxicity
->24 months, controlled
-confirm NOEL
-monitor for carcinogenicity
-monitor for teratogenicity
-monitor for long term metabolic and pharmacokinetic effects
Problems with determining safety
Absolute safety cannot be proven. No protocol is adequate for all compounds.
Extrapolation from high doses to low dose
Extrapolation from animals to humans
Genetic variation is population of animals and humans
High cost
Clinical trials
Why are clinical trials needed?
Variation among people
Variation in course of disease
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