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1)  conditional clinical trial approval
有条件批准临床试验
2)  clinical trial
临床试验
1.
EMEA's consideration on strategy and design of clinical trials for new antibacterial agent;
欧盟医药管理局对新抗菌药物临床试验策略和设计的考虑
2.
FDA's general considerations on the antibacterial dugs clinical trial protocol issues and its enlightenment;
美国FDA对抗菌药物临床试验方案的考虑及其借鉴
3.
FDA's considerations of non-inferiority design used in anti-bacterial drug clinical trials;
美国FDA对抗菌药物临床试验非劣效设计的考虑
3)  clinical trails
临床试验
1.
Objective index for evaluating cerebral atherosclerosis in clinical trails;
脑动脉硬化药物临床试验客观指标探讨
2.
Issues of clinical trails on traditional Chinese new drugs for diabetic polyneuropathy;
糖尿病周围神经病变中药临床试验中的几个问题
3.
Some problems on clinical trails evalution of herbs medicine for insomnia;
失眠症中药新药临床试验疗效评价的几个问题探讨
4)  clinical trials
临床试验
1.
Several Points in Ethic Review in Drug Clinical Trials;
药物临床试验的伦理审查几个要点
2.
Simulations of urn model and RPW rule of adaptive design in clinical trials;
临床试验中自适应设计的urn模型和RPW规则及其模拟
3.
Main points of design about phase I tolerant clinical trials of injectable preparation;
注射剂I期耐受性临床试验方案设计要点
5)  clinical test
临床试验
1.
Method The clinical test of multicentric random parallel control was used.
方法多中心随机平行对照临床试验。
2.
Methods:Through the relevant exprinents and analysis of documental materials, by summarizing the information about the source of ursolic acid and its feature of physics and chemistry, through identification and measure of its structure and content by analysis of its pharmacological functions and by clinical tests and studies on the productive technology.
方法:通过有关试验研究和文献资料的调研分析,综述近年来有关乌索酸的资源情况、理化性质、结构鉴定、含量测定、药理作用、临床试验以及生产工艺方面的研究状况。
6)  clinical trail
临床试验
1.
Hospital ethnic committee construction and clinical trail ethic audit;
医院伦理委员会的建设与临床试验的伦理审核
2.
On Some Issues in Pediatric Clinical Trails
儿童临床试验若干问题的体会
3.
Inspection of ethical issues in multicenter clinical trails in China:a survey of current status
中国大陆部分多中心临床试验伦理审查模式现状调查
补充资料:临床试验
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性质:新药的临床试验一般分三期或四期进行。多数国家按四期进行。工期临床试验(phase工Clinical trials)是在人体进行新药试验的起始期。包括药物耐受性(toierance)试验与药代动力学(pharmacokinetics),生物利用度(bioavailability)研究。Ⅱ期临床试验(phaseⅡ clinicaltrials)要对新药的疗效、适应症、不良反应进行详细考察。通过随机对照临床试验对新药的安全有效性作出确切评价。III期临床试验(phase III clinical trials)为扩大临床试验,目的是在较大范围内对新药的疗效、适应症、不良反应、药物相互作用等进行评价。Ⅳ临床试验(phase IV clinical trials)是在新药投产后进行的,为上市后临床试验或称为上市后药物监察(postmarketing surveillance)。目的是对已在临床广泛应用的新药进行社会性考察,着重于新药的不良反应监察(ad-Verse drug reaction surveillance)。

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