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|Title:||Possible improvement of information sources on hazard and risk|
|Authors:||GRIESINGER Claudius; HOFFMANN Sebastian; KINSNER-OVASKAINEN Agnieszka; COECKE Sandra; HARTUNG Thomas|
|Citation:||HUMAN & EXPERIMENTAL TOXICOLOGY vol. 28 p. 157|
|Publisher:||SAGE PUBLICATIONS LTD|
|Type:||Articles in periodicals and books|
|Abstract:||To improve current information sources it is firstly necessary to improve testing methods. This includes adding high-throughput biological profiling for new chemicals in a tiered approach. Here the high-throughput screening methods used in the pharmaceutical industry, involving an integrated in silico, in vitro, and in vivo approach, may serve as an initial template. In vitro systems may be improved (e.g., by developing human stem cell applications), and in vivo/in vitro test batteries may be optimized (e.g., through minimizing the use of acute toxicity testing, and using transgenic mice appropriately). Testing procedures should focus on human safety, e.g. should also be able to predict rare risks relevant in humans, such as idiosyncratic liver toxicity, without using animal models. Novel methods (e.g., toxicogenomics) should complement classical tools. ¿Gold standards¿ for each endpoint should be defined using species-specific predictive biomarkers, and validation criteria, both for tools and for decision making, should be developed. An emerging concept is microdosing, the evaluation of pharmacokinetic and pharmacodynamic endpoints in humans by administering non-active doses of substances. Information sources could also be improved by building shared, standardized data banks, especially between regulatory authorities or pharmaceutical companies where parallel experimental and clinical data are available. There is a need for increased banking and integration of data across different methodologies, and for availability to this data. This would require a relaxation of patent protection. Tools for decision-making should be efficient, cost-effective, rapid, reliable, transparent, consistent, and standardized. Legislation should be less prescriptive in scope. Decision-making would also be aided if purity and characterization standards were harmonized internationally. Information should be freely available to the public, using simple terminology. Finally, regulators should be willing to accept new tests and paradigms. An initiative is suggested to thoroughly analyse and identify areas in toxicology that are already evidence-based and those that need improvement and might benefit from standardized and evidence-based approaches.|
|JRC Directorate:||Institute for Health and Consumer Protection Historical Collection|
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