由于新药上市前临床试验存在许多局限性,故上市后药品再评价非常重要。
The re-evaluation of the effectiveness of new drugs is of great importance when they are in post-market for there exist some limitations in clinical trials before these drugs are put on the market.
但基于前临床试验结果和研究结果表现出的良好前景,研究者们仍然相信这种治疗程序会成为未来病人们的一个现实的选择。
But based on promising results in preclinical trials and the results of the study, researchers still believe the procedure may be a realistic option for other patients in the future.
在研究方面,为潜在的治疗药物展开昂贵的临床试验前,它能帮助分析。
On the research side, it will help with the analysis of potential drugs before they are deployed in costly clinical trials.
因为在药品得到批准前的临床试验中,确实发现这些药物有降低心脏病的发病率的功效,于是广大医学界更加确认血液中胆固醇含量与心脏病之间的关系。
In those cases, the postapproval trials confirmed that the drugs reduce heart attacks and strokes, adding to confidence about the link between cholesterol and heart disease.
现在提案在网上公布了,批评者有机会在计划于7月份开始的临床试验前加以权衡。
With the proposals now published online, critics have a chance to weigh in before the start of field trials, planned for July.
医药厂商们在得到FDA的批准前,并不需要进行所谓的临床试验,因为这种试验着实花费不菲,需要数千名患者的配合,以观察诸如心脏病等突发疾病的发生率是否有所降低。
They have not had to conduct so-called outcome or events trials beforehand, which are expensive studies that involve thousands of patients and track whether episodes like heart attacks are reduced.
这种药物先前曾经对人进行过实验,因而在一种新药被引入前所要求的耗时的临床试验中具有起步前的优势。
This has previously been tested on humans and so provides a head start in the time-consuming clinical trials required before a new drug can be introduced.
该报告称,除了治疗或预防疾病,在允许进行临床试验前应该对所有存在其他目的的基因编辑进行广泛的公开辩论,包括对非遗传细胞的基因编辑在内。
A broad public debate should be held before permitting clinical trials, even those involving non-inherited DNA, for any purpose other than treating or preventing disease, the report says.
尽管在临床前试验中抗生素格尔德霉素表现出很强的作为抗癌药物的潜力,但是因为其毒性,这种药物没有能成为具有良好临床试验前景的候选药物。
Although there was much preclinical interest in the antibiotic geldanamycin as an anti-cancer drug, it turned out to be a poor candidate for clinical trials because of its toxicity.
下一步可能的工作:一旦该药物的正式的临床前毒理学试验完成,最快在2009年,开始针对MPD患者进行临床试验。
The next likely step will be to open clinical trials for people with MPD as soon as 2009 once formal preclinical toxicology studies are completed.
本文重点阐述了电穿孔在基因治疗中的优势、影响因素及在临床前和临床试验中应用。
This article mainly elaborated the superiority of electroporation in gene therapy and the influencing factors, as well as the applications in the preclinical and clinical trial.
所以您能否临床研究中受益与否或受益大小可能和研究药物临床试验前的研究结果以及试验所处的期别有关。
So whether you can benefit from it or not is related to the result of the research before the clinical trial and the phase of the clinical trial.
他们希望在今年年底前开始动物试验,并且之后不久开始人体临床试验。
They hope to begin animal testing by the end of the year and human clinical trials shortly afterwards.
作为心血管疾病主任,她负责项目领导,提供了多种临床试验前候选药物,其中有一些目前正用于临床研究。
As director of cardiovascular diseases, she provided project leadership for delivering several preclinical drug candidates, a few of which are currently in clinical studies.
每个国家在医疗器械允许进入市场前都必须通过临床试验。
At the national level, different tests including clinical investigations on human subjects, are required before a medical device is granted marketing authorization.
9应当在参加临床试验前每一个对象获得自由给出的知情同意书。
Freelygiven informed consent should be obtained from every subject prior to clinical trial participation.
Kirchhoff说,尚未公布的结果看上去很有希望,且该分子在今年年底前预备进行临床试验。
The unpublished results look promising, Kirchhoff says, and the molecule could be ready for clinical trials by the end of this year.
在随机对照临床试验中并没有重现小规模临床前的调查中观察到的疗效。
To date, randomized, controlled clinical trials have not reproduced the efficacy observed in pre-clinical and small-scale clinical investigations.
对于治疗经前症候群的,借由临床试验来证实其有效性是极少的。
It is rare in PMS management that efficacy claims are substantiated by clinical trials.
一年前,杰龙生物医药公司宣布征集首个胚胎细胞临床试验病人,以治疗脊椎损伤。
Just over a year ago, Geron Corporation announced that they had enrolled their first patients in a clinical trial of embryonic stem cells to treat spinal injuries.
在这种疗法被广泛使用前还需进行进一步的两期临床试验包括持续数年的大样本人群试验。
Before it can be used widely the treatment must undergo two further stages of tests involving larger groups of patients over several years.
临床前研究和临床试验研究显示该药对多种肿瘤有抗肿瘤活性,不良反应较轻。
Preclinical researches and clinical trails show its anti-tumor activity with slight side effects.
应回头仔细看看过去临床试验前的数据(全部的而不是选出的),确定到底有无真有希望的而可进行临床试验。
Looking back carefully at the pre-clinical trial data (the complete set, not just the selected set) and making sure that a promising clinical trial is really worthy of the effort.
应回头仔细看看过去临床试验前的数据(全部的而不是选出的),确定到底有无真有希望的而可进行临床试验。
Looking back carefully at the pre-clinical trial data (the complete set, not just the selected set) and making sure that a promising clinical trial is really worthy of the effort.
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