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Toxicological Sciences 59, 17-36 (2001)
Copyright © 2001 by the Society of Toxicology

Forum

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

James T. MacGregora,1, Jerry M. Collinsa, Yuichi Sugiyamab, Charles A. Tysonc, Jack Deand, Lewis Smithe, Melvin Andersenf, Rodger D. Curreng, J. Brian Houstonh, Fred F. Kadlubari, Gregory L. Kedderisj, Kannan Krishnank, Albert P. Lil, Ralph E. Parchmentm, Kenneth Thummeln, Joseph E. Tomaszewskio, Roger Ulrichp, Alison E. M. Vickersq and Steven A. Wrightonr

a Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland; b Department of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan; c SRI International, Menlo Park, California; d Sanofi Synthelabo, Inc., Malvern, Pennsylvania; e Zeneca Pharmaceuticals, Alderly Park, UK; f Colorado State University, Center for Environmental Toxicology and Technology, Fort Collins, Colorado; g Institute for in Vitro Sciences, Gaithersburg, Maryland; h School of Pharmacy and Pharmaceutical Sciences, University of Manchester, Manchester, UK; i National Center for Toxicological Research, Food and Drug Administration, Jefferson, Arkansas; j Chemical Industry Institute of Toxicology, Research Triangle Park, North Carolina; k Université de Montréal, Santé Environnementale et Santé au Travail, Montréal, Québec, Canada; l In vitro Technologies, Inc., Baltimore, Maryland; m Karmanos Cancer Institute, Wayne State University, Detroit, Michigan; n University of Washington, Department of Pharmaceutics, Seattle, Washington; o National Cancer Institute, Toxicology and Pharmacology Branch, Rockville, Maryland; p Abbott Laboratories, Abbott Park, Illinois; q Novartis Institute for Biomedical Research, Department of Preclinical Safety, East Hanover, New Jersey; and r Eli Lilly & Company, Indianapolis, Indiana

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.

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


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