| 笔译案例信息 |
| 案例标题： |
毒性研究 |
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| 原文： |
The spectrum of findings observed in acute and repeat dose toxicity studies were
comparable following administration of either picoplatin oral formulation or picoplatin IV formulation. The results are consistent with findings for cytotoxic agents within this class and included generally reversible hematolymphopoietic effects, gastrointestinal toxicity (including decreased food consumption and body weight), hepatic toxicity, reproductive effects, and dental changes in the rat and/or dog. Following repeat dosing, the exposures at which the various toxicities occurred in the rat and dog were similar regardless of the route of administration. The major toxicities identified with oral and IV picoplatin were mortality; hematolymphoreticular, GI, hepatic, and reproductive toxicology; and incisor abnormalities.
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| 译文： |
在急性毒性和反复给药毒性研究中观察到吡铂口服给药和静脉（IV）给药后的毒效应谱是相似的。这样的结果与这一类的细胞毒性药物在大鼠和/或狗中所观察到的一致，包括通常可逆的血液淋巴细胞增殖效应，胃肠道毒性（包括进食减少和体重下降），肝毒性，生殖毒性，以及牙齿的变化。重复给药对大鼠和狗发生各种毒性的暴露量相似，与给药途径无关。吡铂口服和静脉给药所确定的主要毒性如下：致死；血液淋巴系统、胃肠道、肝和生殖系统的毒理效应；以及门牙畸形。
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| 案例标题： |
药品包装 |
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| 原文： |
原：Product Description
XX is a low density polyethylene with high rigidity, good opticals and good chemical resistance. It is delivered in pellet form. Target markets are small blow mouldings including packaging of pharmaceuticals and injection moulding for medical devices, closures and seals.
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| 译文： |
译：产品性状
XX为一种低密度聚乙烯，具有高刚性、良好的光学性能及耐化学性。产品为颗粒形式。目标市场为小的吹塑成型制品，包括药品包装，及医疗器械、闭合体（盖）和封口（塞）用注塑成型制品。
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| 案例标题： |
经常翻译药物临床研究报告以及临床研究者手册涉及药物研究相关内容较为广泛。包括理化性质、安全性和有效性、致畸致癌致突变等三致毒性、药代学、药动学等等。 |
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| 原文： |
原：Interactions
In vitro drug metabolism studies show that dutasteride is metabolized by human
cytochrome P450 isoenzyme CYP3A4. Therefore blood concentrations of dutasteride
may increase in the presence of inhibitors of CYP3A4.
Phase II data showed a decrease in clearance of dutasteride when co-administered with the CYP3A4 inhibitors verapamil (37%) and diltiazem (44%). In contrast no decrease in clearance was seen when amlodipine, another calcium channel antagonist, was co-administered with dutasteride. A decrease in clearance and subsequent increase in exposure to dutasteride, in the presence of CYP3A4 inhibitors, is unlikely to be clinically significant due to the wide margin of safety (up to 10-times the recommended dose has been given to patients for up to six months), therefore no dose adjustment is necessary.
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译：相互作用
体外药物代谢研究表明，度他雄胺经由人类细胞色素P450同工酶CYP3A4代谢。因此，当CYP3A4抑制剂存在时，度他雄胺的血药浓度可能会增加。
II 期数据显示度他雄胺与CYP3A4抑制剂维拉帕米(37%)及地尔硫卓(44%)并用时，度他雄胺的清除率会分別降低37%及44%。相比之下，度他雄胺与另一种鈣离子通道阻滞剂氨氯地平并用时，并未观察到度他雄胺清除率降低。在CYP3A4抑制剂存在的情况下，度他雄胺清除率降低而造成随后身体的度他雄胺暴露量增加，因其对于安全性的限度很广，故并不具有临床意义(给予患者高达10倍的推荐剂量长达6个月)，因此无需做剂量的调整。
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