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Pharmacokinetics safety pharmacology testing

Nonclinical pharmacokinetic investigation is helpful when interpreting the data from safety (pharmacological) studies, and it also provides support for toxicology studies. While nonhuman pharmacokinetic parameters are not perfectly predictive of human pharmacokinetics, they do constitute meaningful quantitative data that improve the chances of selecting the correct range of safe doses to test in humans. This dose selection is critically important to the success of clinical trials. [Pg.48]

Nonclinical Studies In vitro (laboratory) or in vivo (animal) pharmacology, toxicology and pharmacokinetic studies that support the testing of a product in humans. Usually at least two species are evaluated prior to Phase I clinical trials. Nonclinical studies continue throughout all phases of research to evaluate long-term safety issues. [Pg.22]

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