In vitro human tissue models in risk assessment: report of a consensus-building workshop.
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.
MacGregor
J T
JT
Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA. macgregorj@cder.fda.gov
Collins
J M
JM
Sugiyama
Y
Y
Tyson
C A
CA
Dean
J
J
Smith
L
L
Andersen
M
M
Curren
R D
RD
Houston
J B
JB
Kadlubar
F F
FF
Kedderis
G L
GL
Krishnan
K
K
Li
A P
AP
Parchment
R E
RE
Thummel
K
K
Tomaszewski
J E
JE
Ulrich
R
R
Vickers
A E
AE
Wrighton
S A
SA
D018929:Cell Culture Techniques; D046508:Culture Techniques; D006801:Humans; D008954:Models, Biological; D018570:Risk Assessment / Q000379:methods*; D015262:Xenobiotics / Q000493:pharmacokinetics* / Q000633:toxicity*
D015262:Xenobiotics