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
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.
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  M. Lohitnavy, Y. Lu, O. Lohitnavy, L. S. Chubb, S. Hirono, and R. S. H. Yang A Possible Role of Multidrug Resistance-Associated Protein 2 (Mrp2) in Hepatic Excretion of PCB126, an Environmental Contaminant: PBPK/PD Modeling Toxicol. Sci., July 1, 2008; 104(1): 27 - 39. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A. K. Froehlich, U. Girreser, and B. Clement METABOLISM OF N-HYDROXYGUANIDINES (N-HYDROXYDEBRISOQUINE) IN HUMAN AND PORCINE HEPATOCYTES: REDUCTION AND FORMATION OF GLUCURONIDES Drug Metab. Dispos., October 1, 2005; 33(10): 1532 - 1537. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
T. S. Poet, H. Wu, J. C. English, and R. A. Corley Metabolic Rate Constants for Hydroquinone in F344 Rat and Human Liver Isolated Hepatocytes: Application to a PBPK Model Toxicol. Sci., November 1, 2004; 82(1): 9 - 25. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
K. L. Willett, R. A. Roth, and L. Walker Workshop Overview: Hepatotoxicity Assessment for Botanical Dietary Supplements Toxicol. Sci., May 1, 2004; 79(1): 4 - 9. [Abstract] [Full Text] [PDF]
|
|