Palmer A K
Huntingdon Research Centre, Huntingdon, Cambridgeshire, England.
Reprod Toxicol. 1993;7 Suppl 1:95-8. doi: 10.1016/0890-6238(93)90073-g.
In summation I start this session with the opinion that in vitro methods cannot be considered as adequate replacements for entire animals at the level of regulatory testing. But, when used to identify mechanisms of action, they can be extremely useful as secondary stage supporting studies. They are of doubtful value for general purpose, broad spectrum screening of single chemical entities or for priority selection of unrelated chemicals. They can be of value for priority selection of homologous series with a known, specific effect on reproduction or development. Such situations are most likely to be present in chemical and drug manufacturing industries where judicious use of in vitro methods in an integrated approach could reduce the number of failures at the later stage of full scale testing. Whether I will need to revise my opinions at the end of this session will depend upon what our speakers have to offer.
总之,我在本次会议开始时认为,在监管测试层面,体外方法不能被视为对整个动物的充分替代。但是,当用于确定作用机制时,它们作为第二阶段的支持性研究可能非常有用。对于单一化学实体的通用、广谱筛选或无关化学品的优先级选择,它们的价值存疑。对于对生殖或发育有已知特定影响的同系物的优先级选择,它们可能有价值。这种情况很可能出现在化学和制药行业,在这些行业中,以综合方法明智地使用体外方法可以减少全面测试后期的失败次数。在本次会议结束时我是否需要修改我的观点将取决于我们的发言者会提供什么内容。