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。”
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。
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。
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。
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。
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。
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。
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。
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。
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