Journal Article

<i>In Vitro</i> Human Tissue Models in Risk Assessment: Report of a Consensus-Building Workshop

James T. MacGregor, Jerry M. Collins, Yuichi Sugiyama, Charles A. Tyson, Jack Dean, Lewis Smith, Melvin Andersen, Rodger D. Curren, J. Brian Houston, Fred F. Kadlubar, Gregory L. Kedderis, Kannan Krishnan, Albert P. Li, Ralph E. Parchment, Kenneth Thummel, Joseph E. Tomaszewski, Roger Ulrich, Alison E. M. Vickers and Steven A. Wrighton

in Toxicological Sciences

Volume 59, issue 1, pages 17-36
Published in print January 2001 | ISSN: 1096-6080
Published online January 2001 | e-ISSN: 1096-0929 | DOI: http://dx.doi.org/10.1093/toxsci/59.1.17
In Vitro Human Tissue Models in Risk Assessment: Report of a Consensus-Building Workshop

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Advances in the technology of human cell and tissue culture and the increasing availability of human tissue for laboratory studies have led to the increased use of in vitro human tissue models in toxicology and pharmacodynamics studies and in quantitative modeling of metabolism, pharmacokinetic behavior, and transport. In recognition of the potential importance of such models in toxicological risk assessment, the Society of Toxicology sponsored a workshop to evaluate the current status of human cell and tissue models and to develop consensus recommendations on the use of such models to improve the scientific basis of risk assessment. This report summarizes the evaluation by invited experts and workshop attendees of the current status of such models for prediction of human metabolism and identification of drug-drug interactions, prediction of human toxicities, and quantitative modeling of pharmacokinetic and pharmaco-toxicodynamic behavior. Consensus recommendations for the application and improvement of current models are presented.

Keywords: risk assessment; human tissues; pharmacologically based pharmacokinetic (PBPK) modeling; hepatocytes; in vitro cell models

Journal Article.  16735 words.  Illustrated.

Subjects: Medical Toxicology ; Toxicology (Non-medical)

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