How does registration as a human drug compounding outsourcing facility under section 503b work?
根据503B章节,如何注册人用药调制外包场所?
Objective To investigate the effect of puerarin injection on human drug-resistant cell line SGC7901/VCR.
目的观察葛根素注射液对人胃癌耐药细胞系SGC7901/VCR的影响。
The research was conducted in rhesus monkeys, which are considered an excellent model of human drug users.
研究所用的恒河猴被认为是人类药瘾者的良好模型。
Drugs made by compounders, including those made at human drug compounding outsourcing facilities, are NOT FDA-approved.
由制药公司制作的药物,包括在人用药调制外包场所制作的,都不是FDA批准的。
Biochemistry accelerated human drug targets for new knowledge and identification, drug synthesis and discovery are very meaningful.
生物化学加速了人类对于新的药物靶点的认识和识别,对于药物合成和发现都极有意义。
If FDA has inspected a human drug compounding outsourcing facility, can I be sure that the drugs I purchase from that facility are safe?
如果FDA已经检查了一个人用药调制外包场所,我能确定我从这个工厂购买的药是安全的吗?
Study author Joe Z. Tsien, a neuroscientist at the Medical College of Georgia, cautioned that formidable obstacles stood in the way of translating the research into a human drug.
研究作者JoeZ . Tsien(钱卓?),一名乔治亚医学院的神经科学家警告说在将研究转化为人类药物的道路上还有难以克服的困难。
In the present time, the behavior of drug addiction can be imitated with increasingly precise animal models, and many characters of human drug addiction can be duplicated in the experimental animals.
目前,药物成瘾行为已有用愈加精确的动物模型来模仿,人的药物成瘾的许多特征已能在实验动物上复制。
Mice transplanted with HEALs exhibit humanized liver functions persistent for weeks, including synthesis of human proteins, human drug metabolism, drug–drug interaction, and drug-induced liver injury.
这组作者报告说,这些肝脏有效地移植了过去,而且这些小鼠在数周时间里展现出了人类肝脏的功能,包括人类蛋白质的合成以及人类药物代谢。
The House bill would authorize the secretary of health and human services to negotiate drug prices in Medicare and Medicaid.
众议院法案将授权卫生与公共服务部部长去协商医疗保险和医疗补助相关的药品价格。
Artemisinin is also a promising potent drug in the treatment of cancer, human parasites such as pneumocystosis.
青蒿素还是一种有前途的有效药物,可用于治疗癌症,人类寄生虫,如肺囊虫病。
The Food and Drug Administration regulates the country’s 2,000 human tissue harvesters but its resources permit only a few hundred inspections per year.
食品及药物管理局监管着全国2,000家人体组织回收机构,但是受资源所限,每年只能进行几百例检查。
The world's first human trials of a swine flu vaccine have begun in Australia, drug company officials said today, as the global death toll from the virus rose to 700.
今日,药品公司的主管宣称,世界首例猪流感疫苗人体试验已于澳大利亚开始进行。迄今为止全球已有700人死于甲型猪流感病例。
Bacterial cells differ from human cells in many fundamental ways, so there are more opportunities for new drug development.
细菌细胞在很多基本方面与人类细胞不同,因此,有更多开发新药物的机会。
Traces of the chemical are often found in mouse and human urine, leading scientists to wonder whether the drug is being made naturally or being delivered by something the subjects consumed.
在老鼠和人的尿中经常可发现这种化学品的痕迹,科学家们不知道这药物是自然产生的还是从实验对象使用的某种东西中带来的。
This year, for the first time, scientists published studies on human diseases and drug responses using IPS cells.
今年,科学家们第一次发表了研究人类疾病及其药物反应时使用多能干细胞的成果。
Right now, scientists know very little about how human genes are linked to drug side effects.
目前科学家对于人类基因与药物副作用之间的关系所知非常有限。
The desire to drug a human body – one's own or another's – into a state of firm arousal or limp submission is as old as humanity itself.
渴望通过服用药物,来调节自身或他人的喜怒哀乐,人类这种行为的历史,和人类本身的历史一样久远。
They inserted the human insulin gene into the common safflower plant, which churns out the drug for a fraction of the cost.
他们将人类胰岛素基因植入普通的红花植物中即可产出胰岛素,但成本只是一小部分。
And if human immune systems react in the same way to the new vaccines as murine ones do, the day when a drug addict might be offered vaccination rather than opprobrium will have come a little closer.
如果人类免疫系统对新疫苗的反应机制就像鼠科动物那样的话,药物成瘾的人获得的是疫苗而非外界辱骂的这一天的来临就更近了。
A drug that stops the HIV virus from stitching itself into human chromosomes is found to fight AIDS in an animal study.
在动物实验中发现一种能阻断艾滋病毒整合入人类染色体的药物。
The Food and Drug Administration regulates the country's 2, 000 human tissue harvesters but its resources permit only a few hundred inspections per year.
美国食品和药品管理局管理着国内的2000个人体组织收购商,不过受其人力财力限制,每年只能检测其中的几百家。
Technically, the U.S. Food and Drug Administration is responsible for ensuring that pet foods, like human foods, are safe to eat, truthfully labeled and produced under sanitary conditions.
从技术上而言,美国食品与药品管理局(FDA)对宠物食品负责,确保它们要像人类食品一样,要能安全食用,如实地贴上标签,并且要在卫生的条件下被生产出来。
Technically, the U.S. Food and Drug Administration is responsible for ensuring that pet foods, like human foods, are safe to eat, truthfully labeled and produced under sanitary conditions.
从技术上而言,美国食品与药品管理局(FDA)对宠物食品负责,确保它们要像人类食品一样,要能安全食用,如实地贴上标签,并且要在卫生的条件下被生产出来。
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