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In vitro human tissue models in risk assessment: report of a consensus-building workshop
J T MacGregor1, J M Collins, Y Sugiyama
1Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA. macgregorj@cder.fda.gov
Summary
Human in vitro tissue models are increasingly used in toxicology and pharmacodynamics. This workshop provides recommendations for using these models to enhance toxicological risk assessment and drug development.
Area of Science:
- Toxicology
- Pharmacology
- Biotechnology
Background:
- Growing use of in vitro human cell and tissue models in research.
- Need for standardized methods in toxicological risk assessment.
- Advancements in human tissue availability for laboratory studies.
Framework:
- Workshop sponsored by the Society of Toxicology.
- Expert evaluation of current in vitro human tissue models.
- Development of consensus recommendations for model application.
Implementation:
- Assessing models for predicting human metabolism and drug-drug interactions.
- Evaluating models for predicting human toxicities.
- Utilizing models for quantitative pharmacokinetic and pharmaco-toxicodynamic analysis.
Implications:
- Improving the scientific basis of toxicological risk assessment.
- Enhancing the prediction of human responses to drugs and chemicals.
- Guiding the application and further development of in vitro models.
