制药工程_专业英语_Unit.ppt

两种类型的安全测试是用来检测候选药物在人体产生肿瘤的能力。第一类是短期的体外遗传毒性试验，例如细菌试验。第二类是是在小鼠和大鼠身上进行的动物长期致癌性研究；他们往往二年的时间长度覆盖了动物寿命的很大一部分。小鼠和大鼠的使用，因为他们的寿命相对较短，体积小，容易获得。此外，有关这些物种的特定种族的自发疾病及肿瘤所积累的知识，大大有助于解释研究结果。 Two types of safety test are used to detect the ability of the drug candidate to produce tumours in man. The first are short-term in vitro genotoxicity tests, for example bacterial tests. The second are long-term animal carcinogenicity studies which are conducted in mice and rats; their length of often 2 years covers a large part of the lifespan of the animal. Mice and rats are used because of their relatively short life span, small size, and ready availability. Also, knowledge, which has accumulated concerning spontaneous diseases and tumours in particular strains of these species, helps greatly in the interpretation of results. 开展长期毒理学和致癌性研究是为了获得试验的批准，并最终向市场推出了人类长期服药的产品。这些研究可能需要在后期临床前/早期临床阶段就开始，以“支持”随后的临床计划。长期毒性试验通常包括两个物种（一个为非啮齿类）的6-12个月持续时间的毒性研究。以前测试到的任何毒性会进行更密切地调查，例如在血液样本中观测到额外的酶。 Long-term toxicology and carcinogenicity studies are conducted in order to obtain approval to test and finally to market a product for chronic administration to man. These studies may need to start during the late preclinical/ early clinical phase in order to ‘support’ the subsequent clinical program. Long-term toxicity studies will normally include toxicity studies of six and twelve months duration in two species (one non-rodent). Any toxicity previously detected may be investigated more closely, for example, extra enzymes looked at in blood samples. 生殖毒理学则是指涉及化合物对繁殖能力、胎儿畸形，产后发育的影响的部分毒理学。在育龄妇女的临床研究之前，监管部门要求有两个物种（通常是大鼠和家兔）以及男性志愿者的临床资料畸形学的数据。在男性受试者的临床研究之前，则不要求生殖方面的数据。 Reproductive toxicology is that part of toxicology dealing with the effect of compounds on reproduction-fertility, foetal abnormalities，post-natal development. Prior to clinical studies in women of child-bearing age, regulatory authorities require teratology data from two species (normally rat and rabbit) as well as clinical