Adjunct information (toxicokinetic data) relating the doses used in a toxicology study to the pharmacokinetic parameters of the candidate drug are used in assessing safe human exposure. Usually, drug plasma concentrations from a small number of animals are used to generate the toxicokinetic data that include a large animal-to-animal variation. A large animal-to-animal variation coupled with a small number of animals, however, does not preclude the use of statistics. Modern statistical methods are available to maximize the information available to the scientist.
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