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Increasing Concern

AND

AND

AND

Poor consistency/ reproducibility in response

AND

No knowledge about concentration of toxicant in blood or tissue

OR

Results obtained with nonstandardized, nonvalidated assays

OR

Results from microarray experiments show a gene expression pattern predictive of dangerous compoundsb

Consistency in response

AND

No knowledge about concentration of toxicant in blood or tissue

Knowledge of presence of toxicant in blood or tissue at concentrations comparable with those causing toxicity in vitro

a Standardized in this context means that the assay is performed consistently across laboratories and often is officially promulgated by a standardization body, such as AOAC International (formerly the Association of Official Analytical Chemists), or the protocol is specified by a regulatory agency.

b Toxicogenomics is a relatively new field, the impact of which is not possible to predict at this point. However, these types of data may become more important as the field progresses. If the value of genomics, proteomics, and other new technologies in identifying dangerous compounds is demonstrated in the future, then such results may warrant more concern than is indicated in this figure.

TABLE 3-9 Spectrum of Concern for Interactions

Increasing Concern

Pharmacokinetic and/or pharmacodynamic data suggesting a supplement-drug/food/other dietary supplement interaction that might lead to a serious adverse event and/or identifying a population at risk for a serious adverse event

Pharmacokinetic and/or pharmacodynamic data documenting a supplement-drug/food/ other dietary supplement interaction that might leads to a serious adverse event and/or identifying a population at risk for a serious adverse event

Pharmacokinetic and/or pharmacodynamic data documenting a supplement-drug/food/other dietary supplement interaction that lead to a serious adverse event



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