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fda批准
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  approved by fda
     Ultracet? tablets (Paracetamol and Tramadol Hydrochloride tablets325mg/37.5mg) was approved by FDA in Aug.2001 for the short-term treatment ofmoderate to severe pain (not more than 5 days).
     2001年8月,FDA批准了37.5 mg盐酸曲马多和325 mg对乙酰氨基酚片(商品名ULTRACET)用于中度至重度急性疼痛的短期治疗(不超过5天)。
短句来源
     The consistency between the 035-E61 and the DAKO reagent approved by FDA was 74%.
     与FDA批准的DAKO公司多抗的阳性染色符合率为 74%。
短句来源
     Since the first HIV screening reagent was approved by FDA to screen the blood in 1985, the fourth generation test has been produced till now.
     自从1985年FDA批准第一个HIV试剂用于献血员筛检以来,迄今已经生产出第4代筛检试剂。
短句来源
     Interleukin-11 is the unique agent approved by FDA for treating platelet declination.
     白细胞介素-11是目前惟一被美国FDA批准上市的防治血小板减少的药物。
短句来源
     USA is the leader of biopharmaceutical industry, with 79 biotech drugs produced by genetic engineering, antibody technology or cytotechnology, being approved by FDA (18 products expressed by E. coli , 8 biotech drugs expressed by yeast, and 53 biomedicines produced by mammalian cell culture) , of which, 64 are recombinant therapeutic proteins.
     美国FDA批准的以基因工程产品、抗体工程产品和细胞工程产品为主要代表的生物技术药物共79种(18种为大肠杆菌表达,8种为酵母表达,53种为哺乳动物细胞培养生产),其中基因重组蛋白质药物为64种。
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  “fda批准”译为未确定词的双语例句
     Many cytokine gene, including IL-2,IL-4,IL-6,IL-7,IL-12,GM-CSF,TNF α,IFNγ, has been approved to apply in the pre-clinic investigation by RAC/FDA.
     许多细胞因子基因(包括IL—2、IL—4、IL—6、IL—7、IL—12、GM—CSF、TNF-α、IFN-γ)被RAC/FDA批准试用于临床,进入Ⅰ、Ⅱ期临床前研究。
短句来源
     Herceptin that targeted the HER-2/neu protein of the surface of the tumor cells is a humanized monoclonal antibody, and it was authorized by FDA in 1998. Now, it becomes one of the drugs of HER-2/neu-overexpressing advanced breast cancer treatment.
     赫赛汀(Herceptin)就是目前针对肿瘤细胞表面HER-2/neu蛋白靶向治疗的人鼠嵌合型单克隆抗体,1998年被美国FDA批准上市,可作为HER-2/neu过度表达晚期乳腺癌的治疗药物之一。
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     FDA approved radiopharmaceuticals
     获得FDA批准的放射性药物
短句来源
     Augmentation therapy for sever deficiency of α1-AT first achieved US Food and Drug Administration approval in 1989 with a pasteurized pooled human plasma product.
     1989年,人血浆α1-AT制剂获得美国FDA批准用于严重α1-AT缺乏的患者的替代治疗。
短句来源
     Telmisartan, as a new benzimidazol angiotensin II receptor antagonist, was developed by Boehringer Ingelheim Co.
     替米沙坦(Telmisartan,商品名:Micardis)为新一代苯并咪唑类血管紧张素Ⅱ受体拮抗剂,由德国Boehringer Ingelheim公司研制,经美国FDA批准用于治疗原发性高血压。
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     FDA approved radiopharmaceuticals
     获得FDA批准的放射性药物
短句来源
     FDA OKs First in New Class of Antibiotics
     一种新的抗生素获FDA批准
短句来源
     On Institution about the Ratification of Law and Regulation
     论法规批准制度
短句来源
     This Project is supported by the National Natural Science Foundation (Grant No.10147201)
     (基金批准号:10147201)
短句来源
     Phenylpropanolamine research from FDA
     FDA对苯丙醇胺的研究
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  approved by fda
Currently, there are 30 drugs or combinations of drugs approved by FDA.
      
Additionally, a request to permit the use of ionizing radiation on red meat products was recently approved by FDA.
      
Azelastine nasal spray was approved by FDA in November of 1996.
      
A combination platinum/silver impregnated catheter is available in Europe and has recently been approved by FDA for use in the United States.
      
A PEGylated aptamer, the 28mer oligomer aptanib, has already been approved by FDA for the treatment of age-related macular degeneration of retina.
      
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The worldwide medical laser market, including The United States, Western Europe and Japan, financial analysis of key companies, identifying new business opportunities, new product FDA approvals, and product-line advances in laser ophthalmology, surgery, angioplasty, keratoplasty, photodynamic treatment, biostimulation, diagnosis and infrared optical fiber are introduced. The status and some problems of medical laser industry in China are briefly presented.

本文介绍了包括美国、西欧及日本在内的世界医用激光市场,主要公司的运行和财政分析,激光医学各科(眼科、外科、心血管、角膜成形、光动力学、碎石术、诊断、红外光纤)的市场规模及近年被FDA批准销售的激光系统。简述了我国医用激光产业的状况及存在的问题。

This article describes the general information of the new chemical entities for human therapeutic use appeared on the world market for the first time and the new molecular entities approved by FDA of U.S.A.during 1990~1992 as well as the drugs having a most ready sale in the world during 1985~1992.The thinking of design for development of synthetic drugs and the way for research and development of breakthrough products in China are discussed.

本文介绍1990~1992年世界首次上市的新化学物体,美国FDA批准的新分子实体以及1985~1992年世界最畅销药物的概况。探讨了创制合成新药的设计思路以及我国研究开发突破性新药的选题方向。

Hydroxyapatite cement (HAC) is a new- type hydroxyapatic artificial bone material. In 1991, HAC was approved by Food and Drug Administration in America for its investigation study in human subjects with cranial defects. A si-miliar product has been produced by the Physicial and Technological Institute of East China recently. Using the extracts of HAC by physiological saline, we carried on a biological safety evaluation of this HAC material. The evaluation tests included cell culture cytotoxicity, systemic injection...

Hydroxyapatite cement (HAC) is a new- type hydroxyapatic artificial bone material. In 1991, HAC was approved by Food and Drug Administration in America for its investigation study in human subjects with cranial defects. A si-miliar product has been produced by the Physicial and Technological Institute of East China recently. Using the extracts of HAC by physiological saline, we carried on a biological safety evaluation of this HAC material. The evaluation tests included cell culture cytotoxicity, systemic injection acute toxicity, Ames test, micronucleus test and UDS( unscheduled DNA synthesis) test. The results showed that the extracts had no inhabitory effect on the growth or the cultured cells, no mutagenic effect on the DNA. These suggeat us that applications of HAC in human subjects may be of safety.

羟基磷灰石水泥(HAC)是新型的羟基磷灰石类人工骨材料。1991年得到美国食品与药物管理局(FDA)的批准,在临床试用,用于颅骨缺损的填充治疗。华东理工大学最近研制出类似的HAC。我们用它的生理盐水浸出液对其进行了生物学安全性试验,包括细胞培养毒性试验、全身注射毒性试验、Ames试验、微核试验及UDS试验。结果表明HAC的浸出液对培养细胞的生长无抑制作用,对体细胞的遗传物质(染色体、DNA)无致突变作用。上述结果提示我们,HAC用于人体是安全的。

 
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