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新药临床试验
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  new-drug clinical trial
     The Statistics Methods and Application about Repeated Data in New-Drug Clinical Trial
     新药临床试验中重复测量资料的几种统计分析方法及其应用
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     Application of Generalized Linear Models in New-Drug Clinical Trial
     广义线性模型在新药临床试验中的应用
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     Methods In conjunction with the instance of the clinical trial, to construct the correlation structures within subject, then to expatiate the theory about univariate ANOVA, Multivariate analysis of variance, mixed linear model and generalized estimating equation, and bring forth the step of these methods for new-drug clinical trial statistical analyse.
     方法 结合新药临床试验的实例讨论重复测量数据的组内相关结构,阐述单变量方差分析、多变量方差分析、混合线性模型、广义估计方程处理新药临床试验中重复测量资料原理和步骤。
短句来源
     Results and Conclusions To show the applications of univariate ANOVA, Multivariate analysis of variance, mixed linear model and generalized estimating equation at new-drug clinical trial statistical analysis in conjunction with the instance. To demonstrate a series of resolve for non-independent data and to educe theirstrong suits, disadvantage and applicability.
     结果与结论 通过实例阐述了单变量方差分析、多变量方差分析、混合线性模型、广义估计方程在新药临床试验分析中的应用,对常用分析方法感到棘手的数据非独立性问题展示了多种不同的解决方法,得出了各自的优缺点、适用条件。
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  new drug clinical trials
     Problems and countermeasures of GCP practice in the new drug clinical trials
     新药临床试验中GCP实施的问题与对策
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     Methods Based upon the relative laws, regulations, principles and social ethics and morals, the medical ethical issues in new drug clinical trials were discussed.
     方法以相关的法律、法规、原则、规范以及社会伦理、道德为依据,探讨新药临床试验中的医学伦理学问题。
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     Conclusion The people implemented trials should abide by relative laws and regulations so as to solve the related medical ethical problems during new drug clinical trials.
     结论在新药临床试验研究过程中,试验者必须执行和遵守相关的法律法规,解决好试验阶段相关的医学伦理学问题。
短句来源
     To study human bioequiavailability is one of the main researches on new drug clinical trials, which is characterized by multiple sampling points and short sampling intervals.
     人体生物等效性研究是新药临床试验的主要内容之一,具有取样点多、取样间隔短的特点,如何避免取样时间点的重叠,保障试验的有序进行,确保数据的可靠,是我们在进行该类试验时必须首要考虑的问题。
短句来源
     Objective To clarify how to solve the relative medical ethical problems by discussing the medical ethical issues during new drug clinical trials.
     目的通过对新药临床试验中存在的医学伦理学问题的探讨,阐明在新药临床试验研究过程中,如何解决好试验阶段相关的医学伦理学问题。
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  clinical trials of investigational new drugs
     This article briefly introduces the management of clinical trials of investigational new drugs, hospital-made preparations,post-marketing drugs and other types of clinical trials. The WHO International Clinical Trial Register Platform(WHO ICTRP),Chinese Clinical Trial Register (ChiCTR) and Chinese Clinical Trial Registration and Publishing Collaboration(ChiCTRPC)are also described.
     本文介绍了当前新药临床试验、院内制剂、上市后药物临床试验及其他类型临床试验的管理情况,世界卫生组织临床试验注册平台(WHO ICTRP)的结构和运作机制和全球临床试验注册制度建立概况,中国临床试验注册中心和中国临床试验注册与发表协作网及其运作机制;
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  “新药临床试验”译为未确定词的双语例句
     Strategies to control confounding factors in clinical trials
     关于新药临床试验中控制混杂因素的几点意见
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     Principle and manipulation of clinical trials(6) ——Guidelines for standard operating procedure (continued 1)
     新药临床试验的原理与操作(6)——统计学处理的标准操作规程指南(续1)
短句来源
     A SAS macro for statistical analyses of count data in clinical trial of new drug
     新药临床试验数据中计数资料统计分析的SAS宏实现
短句来源
     Problems and countermeasures of choice of control drug in clinical trials of the traditional Chinese new drug
     中药新药临床试验对照药选择的问题与对策
短句来源
     This paper describes the whole developing process of the testing management system by analyzing component technology.
     本文通过对组件技术的分析和研究描述了中药新药临床试验管理系统基于CBD开发模式的整个开发过程。
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A two-period cross-over design in new clinical trials is proposed. By the design the within-patient comparisons between drugs and between periods can be made. The tests of period-effect and drug-period interaction may explain whether the spontaneous changes of effect of periods and the carry-over effect of drugs exist respectively.

本文提出新药临床试验中最常用的2周期交叉设计分析法。在病人内比较药物差别;检验药物的周期效应与药物-周期交互作用,前者可分析病人反应是否有与药物无关的自然变迁,后者可分析药物有无后遗效应。

Results of reference values of six items of liver function (ALT,AST, ALP, TP, ALb, Tbil)obtained from 213 healthy male students with the age of 21~25 years old who participated in phase I clinical trials of new drugs conducted by the Institute of Clinical Pharmacology, the first hospital of Beijing Medical University during past five years were compared with those indicated in “National Guideline for the Operation of Clinical Laboratory Tests, 2nd ed.1997",and objects were considered for analyzing the differences...

Results of reference values of six items of liver function (ALT,AST, ALP, TP, ALb, Tbil)obtained from 213 healthy male students with the age of 21~25 years old who participated in phase I clinical trials of new drugs conducted by the Institute of Clinical Pharmacology, the first hospital of Beijing Medical University during past five years were compared with those indicated in “National Guideline for the Operation of Clinical Laboratory Tests, 2nd ed.1997",and objects were considered for analyzing the differences in reference values. All volunteers were healthy male students, the differences in age were small, they all passed careful physical examination and clinical laboratory tests proving they were healthy, therefore the reference values of ALT(2~26 U·L-1),AST(6~34 U·L-1),ALP(33~111 U·L-1) etc of them were lower than ALT(5~40U·L-1), AST(8~40 U·L-1), ALP (40~150 U·L-1) indicated in "National Guideline for the Operation of Clinical Laboratory Tests,2nd ed.1997." It is suggested that the results can offer reference in clinical trials of new drugs for safety evaluation.

本文对本研究所近五年来新药I期临床试验中入选的213名健康男性大学生(年龄21~25岁)的6项肝功指标(ALT,AST,ALP,TP,ALb,Tbil)测定结果与《全国临床检验操作规程(第二版)1997》[7]进行比较,并对二者存在的差别从实验对象进行了分析。本组受试者均为健康男性大学生,年龄差距小,均经严格体检证明健康,故ALT(2~26U·L-1)、AST(6~34U·L-1)、与ALP(33~111U·L-1)等正常值均低于《全国临床检验操作规程(第二版)1997》[7]ALT(5~40U·L-1)、AST(8~40U·L-1)、ALP(40~150U·L-1)等值。可供新药临床试验中对新药进行安全性评价时参考。

As more and more randomized active controlled clinical trials to show efficacy of a new drug is as good as or not worse than a known effective drug are used, the objective of clinical investigation changes. The evaluation of noninferiority/equivalence rather than superiority of the new drug to an existing effective standard drug become more and more indispensable. Based on the principles and requirements of the International Conference on Harmonization (ICH) and some published literatures about noninferiority/equivalence...

As more and more randomized active controlled clinical trials to show efficacy of a new drug is as good as or not worse than a known effective drug are used, the objective of clinical investigation changes. The evaluation of noninferiority/equivalence rather than superiority of the new drug to an existing effective standard drug become more and more indispensable. Based on the principles and requirements of the International Conference on Harmonization (ICH) and some published literatures about noninferiority/equivalence trials, we prepared this paper, hoping to introduce statistical issues in noninferiority/ equivalence trials. The paper reviews the choice of noninferiority/equivalence margin, the forms of the null and alternative hypotheses and confidence intervals, and the determination of sample size and power of test. The main pods are illustrated with corresponding examples. We conclude by giving some miscellaneous considerations to help understand and conduct the noninferiority/equivalence trials. In summary, the authors strongly feel that there is a need to educate biostatistician and clinical trialists on the importance of using the right statistical methods when they are employed to investigate clinical noninferiority/ equivalence.

随着医药事业的发展进步,许多疾病的治疗已有现成的有效药物,以阳性标准治疗而不是安慰剂作为对照的临床试验愈来愈多,导致了许多新药临床研究的目的发生转变,更多遇到的情形是要确认新药的临床疗效是否不差于或者相当于标准的有效药物,因而非劣效性/等效性试验在新药临床试验中占有较大的比例。为此,本文主要根据国际上实施非劣效性/等效性试验的原则和要求,对相应的一些统计学事项进行论述。结合有关的事例,作者较为系统地介绍了临床非劣效性/等效性界值的确定、统计学推断的假设检验和可信区间方法、样本含量及检验效能的计算等。就实际应用中的有关问题,作者还提出进一步的建议和讨论。相信这对于加强生物统计学在我国临床试验中的正确应用,推动我国临床试验与国际的接轨具有重要的现实意义。

 
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