文档介绍：Part sixth Safety evaluation (安全评估)
Part sixth Safety evaluation (安全评估)
The objective of animal toxicology testing,carried out prior to the administration of a drug to man,is to pounds of eptable toxicity and to identify potential ans and timings for adverse effects of the drug.
对动物毒理学测试的目标,实施在药品监督管理局把药物用在人身上测试之前,是拒绝不可接受的毒性化合物,并确定为潜在的药物不良反应的靶器官和时序。
This means that in early human studies ans and tissues can be monitored with particular attention.
这意味着,在研究这些早期人类器官和组织,可特别注意监测。
Part sixth Safety evaluation (安全评估)
It is important to establish whether toxic effects are reversible or irreversible,whether they can be prevented and,if possible,the mechanism of the toxicological effects. It is also important to interrelate drug response to blood levels in humans and blood levels in various animal species.
确定是否有毒或者这种影响是可逆的还是不可逆的,以及它们是否可以预防是很重要的,如果可能的话,是否能够确定该毒性作用的机制。把药物在人类血液中的反应水平以及在对各种动物血液的反应水平相联系起来也是很重要的。
toxicology noun 毒理学、毒物学/toxicologist 毒理学家
toxicological adj 有毒性的
administration noun 药品监督管理局(Food and Drug Administration,FDA)
reversible/irreversible 可逆的/不可逆的
reversible reaction/irreversible reaction 可逆反应/不可逆反应
if possible 如果可能的话
Part sixth Safety evaluation (安全评估)
The toxicological studies required for the evaluation of a drug candidate in man will be relevant to its proposed clinical use in terms of route of administration and duration of treatment of the clinical studies.
在人的一个候选药物的评价所需的毒理学研究将对其提出的临床应用在管理和临床研究的治疗时间相关的路线。
Part sixth Safety evaluation (安全评估)
The size and frequency of the doses and the duration of the toxicology studies are major determinants of permissible tests in man.
允许在人身上试验的主要决定因素是剂量的大小和频率以及持续时间的毒理学研究。
Countries,including UK,USA,Australia,and Nordic countries,have regulatory guidelines which relate the duration of treatment allowed in man to the length of toxicity studies required in two species. Points from the guidelines are referenced in the subsequent sections.
包括英国,美国,澳大利亚和北欧等国家,其中有涉及在人的毒性研究所需要的时间和对两个物种的毒性研究所允许的疗程长度已经有了监管指引。其中一