Developing in vitro test methodologies sufficient for chemical safety assessments in the 21 st century
作者单位：Chief Science OfficerThe Hamner Institutes for Health SciencesResearch Triangle Park
会议名称：《中国毒理学会第六届全国毒理学大会》
会议日期：2013年
学科分类：100405[医学-卫生毒理学] 1004[医学-公共卫生与预防医学(可授医学、理学学位)] 10[医学]
摘 要：The past 50 years witnessed steadily increasing pressures to reduce animal testing in assessing the safety of chemicals and ***,the major concerns were ethical due to the large numbers of animals used in these *** European Union(EU) has maintained this strong emphasis on ethics,enacting reduction/elimination of animals for much toxicity testing into *** North America, there was a realization that a regulatory system layering in-life study on in-life study was costly,expensive and slow:there were too many chemicals requiring testing and too few resources to get the testing *** US Environmental Protection Agency(EPA) proactively developed plans for increased use of computational and molecular/cellular technologies in their computational toxicology framework paper in 2004.A US National Academy of Sciences(NAS) committee in 2007 then recommended a new testing strategy that would require only in vitro test *** past 5 to 6 years has seen the completion of early phases of high throughput(HT) screening,appearance of new methods for comparing in vitro bioactivity results with anticipated human exposures,and a flurry of activity-research,scientific meetings, and product commercialization-to hasten change from in life *** talk emphasizes a group of initiatives to make in vitro test results sufficient for safety assessment and notes some of the looming challenges. The US EPA’s ToxCast efforts on HT-screening,HT-exposure assessment with evolving tools for HT-provisional risk assessment has provided data sets to ignite a broad debate on the future of these *** genomic approaches support both dose response and identification of modes of action of *** tools may permit a transitional tiered-approach,triaging out many chemicals before moving to in life *** Hamner,we are pursuing case studies of compounds with known modes of action in order to develop the full suite of tools necessary for safety assessment