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13:08 Jun 29, 2008 |
English to Chinese translations [PRO] Medical - Medical: Pharmaceuticals | |||||||
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| Selected response from: Han Li China Local time: 19:29 | ||||||
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Summary of answers provided | ||||
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3 +1 | GLP = good laboratory practice |
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3 +1 | 非优良实验室规范 |
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non-glp GLP = good laboratory practice Explanation: http://216.239.59.104/search?q=cache:AdQDga_KbbsJ:www.rtctox... I don't do Chinese, but his may help you find what you require. -------------------------------------------------- Note added at 1 hr (2008-06-29 14:17:42 GMT) -------------------------------------------------- Canadian Food Inspection Agency - Livestock Feeds - Good ... This is a Trade Memo regarding good laboratory practices protocol for feed ... The following protocol was developed to ensure that the method and test ... www.inspection.gc.ca/english/anima/feebet/trademem/t3151e.s... - 15k - Cached - Similar pages |
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non-glp 非优良实验室规范 Explanation: 《药物非临床研究质量管理规范》也没有错啊,非临床研究阶段一般即是实验室阶段。 另外从网上copy了一段,供你参考: 生产药物,每一粒制成品去到病人的身体中,都是独当一面,非得要它施展浑身解数不可,否则就是货不对办,轻则不称职,帮不了病人,重则「死得人多」。在病人而言,是须要「靠」它。在这个「靠」的程度上,需要取得的是药的全部力量,不可打折扣。纵使每一粒药本身只是整个疗程中的一个角色而已,但若要所有角色发挥整体效果,任何一个都不能有差池。因此,有所谓优良生产程序(Good Manufacturing Practice),务求每一粒制成品都是杰作,最低限度是完美。 但当一个药尚在概念阶段,处于研发中,未经FDA审批之前,它只不过是实验室中的一个试验品。在试验中,当然须有各式各样、反来覆去的测试步骤,但并非每一个步骤都是举足轻重,动辄得咎。 因此,药厂内有两类实验室,第一类具优良实验程序(Good Laboratory Practice, GLP),第二类则属非优良实验程序(Non-GLP)。后者容易令人误解。是否Non-GLP代表「马马虎虎」?不是。所谓GLP水平,是要能严格遵从美国食物与药物管理局(FDA)十分严谨的一系列实验程序,主要是用在动物的毒性测试上,得到的数据将会成为概念药申请临床测试的基础,不可有丝毫失误。 至于Non-GLP,是一般实验室的专业守则;虽然「一般」(逊于GLP),但亦是极之认真。药厂中90%以上的实验室都属Non-GLP。处理的工作包括一些化学分子生物学、细胞学和药理学方面的实验。 -------------------------------------------------- Note added at 1 hr (2008-06-29 14:46:32 GMT) -------------------------------------------------- practice在国内的官方说法都是作“规范”讲 Reference: http://www.gznf.net/index.php/71982/viewspace-405926.html |
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