AIM: To introduce the concept of bridging study and its strategies in clinical trials for new drug application.
目的：介绍新药临床试验中桥接试验的概念和实施策略。
In this paper we study a free boundary problem modelling the growth of an avascular tumor with drug application.
本文，我们研究了在药物作用下未血管化肿瘤生长的数学模型，该模型是一个偏微分方程的自由边界问题。
CONCLUSION Performing the ear secretion culture and drug sensitive test is of great value to clinical drug application.
结论耳部炎性疾病应行分泌物培养及药物敏感试验，对指导临床用药有指导意义。
Approval of a drug requires the submission and approval of a new drug application or an abbreviated new drug application.
药物的批准要求一个新药或者仿制药的递交和批准。
Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application.
如果制药公司希望标记OT C但没有达到专著要求的，均可以提交新药上市的申请和获得注册新药的许可。
To explore outpatient pharmacy pharmaceutical service mode, so as to enhance drug compliance in patients, promote rational drug application.
目的探讨门诊药房药学服务模式，提高患者用药依从性，促进合理用药。
Drug registration is classified into new drug application, supplementary application, license renew application, and import drug application.
药品注册分为新药注册申请、补充申请、药品再注册申请和进口药品申请。
Indicate whether individuals responsible for data integrity lapses remain able to influence CGMP-related or drug application data at your firm.
说明是否对数据完整性问题承担责任的个人仍有能力对你公司对CGMP相关或药物应用数据产生影响。
Following the withdrawal, any future use of Mylotarg in the United States will require submission of an investigational new drug application to FDA.
在此次撤市之后，麦罗塔将来在美国的任何一种使用都将需要向FDA提交一项研究性新药申请。
This platform is composed by GRP experiment management system, GLP new drug application system and drug discovery standard workflow management system.
该平台由GRP实验管理系统、GLP新药申报系统和新药研发标准化流程管理系统组成。
This process allows a company to file the sections of the New Drug Application (NDA) as they become available instead of filing all the sections at once.
这个过程允许公司提交的新药申请（NDA），因为它们变得可用，而不是提出在一旦所有的部分章节。
Conclusion Monitoring ADR is the effective method to prevent the occurrence of ADR, promote reasonable drug application and ensure the safety of drug use.
结论监测药品不良反应，预防药品不良反应的发生，是促进合理用药及保障用药安全的有效手段。
Generic drug application reviewers focus on bioequivalence data, chemistry and microbiology data, requests for plant inspection, and drug labeling information.
仿制药申请的的评审官着重于生物等效性资料，化学和生物资料，工厂检查的要求和药品标签信息等。
An FDA spokeswoman defended the agency's handling of the review, saying that "overall, this is the most transparent manner ever used for a new animal drug application."
一个FDA的发言人这样为FDA的立场辩护：“说到底，这已经是一个新的兽药申请审批中从没有过的透明度了。”
Its effect on suppressing asthma is weak but it can enhance the effect of anti histamine of rabbit if the duration of drug application is longer and amount is larger.
另有袪痰作用(小白鼠酚红法)，止喘作用弱，如用药时间延长，用量增加时，能加强家兔抗组织胺的作用。
These results suggest that gender, age, kidney function, digestive tract disease history, and drug application are closely related to anemia after kidney transplantation.
分析表明，性别、年龄、肾功能、消化道疾病史、药物因素等与肾移植后贫血的发生密切相关。
Disease rooted from losing harmony. The harmony restored has its laws, including the reconciliation of man and nature, man's own state of mind and drug application to reconcile.
致病即失“和”，复合有其法，包括人与自然调和、人自身心态的调和以及疾病之后的药物应用调和。
There existing blood-brain-barrier(BBB) problem, a variety of potential drugs for curing the illness of nerve center system(NCS) are restricted in the process of drug application.
由于血脑屏障的存在，许多神经中枢系统疾病的潜在治疗药物在应用中受到限制。
Method: Every link in the whole chain of the application of MEBO should be considered carefully including time interval of drug application, drug applying method and every operation.
方法：分析在MEBO换药技术中换药时间、换药方法以及换药操作的细微环节。
Based on the therapeutic characteristics of these drugs and the questions in new photosensitive drug application in China, in this review we indicated the key points of safety and effectiveness...
现结合有关光敏剂和光动力治疗的治疗学特点、当前国内光敏剂申报中存在的问题等，探讨光敏药物研发关键点，以期为国内该类药物安全有效性的综合评价提供参考。
The company intends to complete additional trials of the compound by mid-2011, and to submit an application for approval to the US Food and Drug Administration about six months later.
该公司拟在2011年年中完成该药物剩余的试验，并在六个月后向美国食品和药物管理局提交批准申请。
In March, Roche and Biogen Idec filed an application with the U.S. Food and Drug Administration seeking expanded approval of Rituxan as reflected in the study's findings.
三月份，罗氏和生物基因艾迪克就研究中的新发现向美国食品药品监督管理局(Foodand Drug Administration)提出新应用的申请。
The supercomputer's applications include drug development, disaster planning and application, and other types of research that involve processing and analyzing huge quantities of data.
该超级电脑的适用领域包括新药开发、灾难应对计划安排与执行及其他各类研究——只要此种研究需要处理和分析海量数据。
New opportunity and wide application career for the research of formulations of drug and pesticide are provided by nanotechnology.
纳米技术为医药和农药剂型的研究提供了新机遇，具有广阔的应用前景。
METHOD: the principle of Markov model was expounded and its application in the forecasting of drug market was illustrated with examples.
方法：阐述马尔科夫模型的原理，通过实例说明其在药品经济预测中的应用。
For drugs with drug approval Numbers, the application of writing off the original drug approval Numbers by the holders shall be submitted simultaneously.
对于持有药品批准文号的，应当同时提交持有药品批准文号的药品生产企业提出注销所转让品种药品批准文号的申请。
During the workshop, participants will propose a specific drug for a specific rare disease and work on an orphan designation application to submit to the FDA at the conclusion of the workshop.
研讨会期间，与会者将提出一个具体的孤儿药物按照FDA的孤儿药物审批过程进行研讨，并将其申请提交给FDA作为研讨会的总结。
The approval Letter of Supplementary application and a drug approval number will be issued for qualified application.
符合规定的，发给《药品补充申请批件》及药品批准文号。
But the researchers already have positive safety data from tests of arginine-transporter technology in another application, one that does not involve drug resistance, so they are optimistic.
但是，研究人员已经从别的实验中(不是耐药性实验)获得了精氨酸载体的安全性数据，所以他们对此持乐观态度。
Describe and contrast the currently available drug delivery methods and the mechanisms underlying the scope of their application.
叙述和对照现今药物取得的方法和构成它们施用范围的机制？
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