The objective of this review is to highlight the continued exclusion of discussion in the literature regarding alternative causes and proper causality assessment of cases of hepatotoxicity when use of dietary suppleme...The objective of this review is to highlight the continued exclusion of discussion in the literature regarding alternative causes and proper causality assessment of cases of hepatotoxicity when use of dietary supplements is reported. Though independent experts are working diligently to advance the discussion related to alternative causes of hepatotoxicity resulting in idiosyncratic drug-induced liver injury/herb-induced liver injury (DILI/HILI), the literature continues to recite the same cases, such as those presented here, to reiterate potentially biased positions and ignore current, standardized and valid evaluations utilizing the Roussel Uclaf Causality Assessment Method (RUCAM). Several historical cases purporting hepatotoxicity induced by use of dietary supplements are presented in this review to demonstrate how such cases may be improperly assessed due to bias, inconsistent use of causality assessment methods, as well as use of causality assessment methods deemed obsolete. This in essence, delays any true progress in establishing sound criteria to determine and address the actual cause(s) of DILI/HILI.展开更多
Bioelution, the measuring of in vitro metal ion release from metals or metal compounds in simulated body fluids, can be used as a tool to measure bioaccessibility of metals and metal compounds, and as such provide an ...Bioelution, the measuring of in vitro metal ion release from metals or metal compounds in simulated body fluids, can be used as a tool to measure bioaccessibility of metals and metal compounds, and as such provide an estimate of their bioavailability. Comparable bioelution results can allow grouping of substances within a “metal” family. By referring to toxicity data on a metal substance (reference substance) within the group, predictions on the hazard of the other substances in the group can be established. This paper discusses how bioelution testing of metals and metal compounds can be used as an alternative to animal testing for obtaining basic information on their potential toxicity, while allowing compliance with strict information requirements. Two human health hazard endpoints are used to illustrate how bioelution can become part of a testing programme and in particular, target the requirement for new studies and minimise the need for animal testing. In these cases, it is shown how bioelution can be used to predict the hazard of several indium compounds as a first screening.展开更多
文摘The objective of this review is to highlight the continued exclusion of discussion in the literature regarding alternative causes and proper causality assessment of cases of hepatotoxicity when use of dietary supplements is reported. Though independent experts are working diligently to advance the discussion related to alternative causes of hepatotoxicity resulting in idiosyncratic drug-induced liver injury/herb-induced liver injury (DILI/HILI), the literature continues to recite the same cases, such as those presented here, to reiterate potentially biased positions and ignore current, standardized and valid evaluations utilizing the Roussel Uclaf Causality Assessment Method (RUCAM). Several historical cases purporting hepatotoxicity induced by use of dietary supplements are presented in this review to demonstrate how such cases may be improperly assessed due to bias, inconsistent use of causality assessment methods, as well as use of causality assessment methods deemed obsolete. This in essence, delays any true progress in establishing sound criteria to determine and address the actual cause(s) of DILI/HILI.
文摘Bioelution, the measuring of in vitro metal ion release from metals or metal compounds in simulated body fluids, can be used as a tool to measure bioaccessibility of metals and metal compounds, and as such provide an estimate of their bioavailability. Comparable bioelution results can allow grouping of substances within a “metal” family. By referring to toxicity data on a metal substance (reference substance) within the group, predictions on the hazard of the other substances in the group can be established. This paper discusses how bioelution testing of metals and metal compounds can be used as an alternative to animal testing for obtaining basic information on their potential toxicity, while allowing compliance with strict information requirements. Two human health hazard endpoints are used to illustrate how bioelution can become part of a testing programme and in particular, target the requirement for new studies and minimise the need for animal testing. In these cases, it is shown how bioelution can be used to predict the hazard of several indium compounds as a first screening.
