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Smith DA, Humphrey MJ, Charuel C. Design of toxicokinetic studies. Xenobiotica. 1990;20(11):1187-99doi: 10.3109/00498259009046838.
Smith, D. A., Humphrey, M. J., & Charuel, C. (1990). Design of toxicokinetic studies. Xenobiotica; the fate of foreign compounds in biological systems, 20(11), 1187-99. https://doi.org/10.3109/00498259009046838
Smith, D A, et al. "Design of toxicokinetic studies." Xenobiotica; the fate of foreign compounds in biological systems vol. 20,11 (1990): 1187-99. doi: https://doi.org/10.3109/00498259009046838
Smith DA, Humphrey MJ, Charuel C. Design of toxicokinetic studies. Xenobiotica. 1990 Nov;20(11):1187-99. doi: 10.3109/00498259009046838. PMID: 2275214.
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Xenobiotica. 1990 Nov;20(11):1187-99. doi: 10.3109/00498259009046838.

Design of toxicokinetic studies.

Xenobiotica; the fate of foreign compounds in biological systems

D A Smith, M J Humphrey, C Charuel

Affiliations

  1. Department of Drug Metabolism, Pfizer Central Research, Sandwich, Kent, UK.

PMID: 2275214 DOI: 10.3109/00498259009046838

Abstract

1. Toxicokinetics is defined as pharmacokinetic studies in animals during actual toxicity studies or under conditions mimicking them (species, duration, dose level, etc.). 2. Toxicology studies require toxicokinetics to check whether systemic exposure reflects administered dose. In particular, it is important to know whether the absence of toxicity at a given dose is due to the innocuousness of the compound or to its poor bioavailability. 3. Pivotal toxicology studies may require different toxicokinetic support than that of early studies, as more is learned of the compound and its metabolites. Considerations need to be placed on such factors as the choice of biological matrix for drug assay, the relevance of metabolites, and which dose levels require the most pharmacokinetic investigation.

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