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3(19) Pharmaceutical Protocols
-3 dose levels
-teratogen: mis-read DNA
-must be tested and evaluated toxicologically in all aspects
-only chemicals judged safe are accepted
-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
-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
Why are clinical trials needed?
Variation among people
Variation in course of disease
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