【new_drug_application】什么意思_英语new_drug_application的翻译_音标_读音_用法_例句_在线翻译

new drug application

新药申请：指在美国，药品赞助商正式提议美国食品和药物管理局批准新药品销售和营销的途径。大约30%或更少的初始药物候选者通过整个多年的药物开发过程，最终成功获得批准的新药申请。

新药申请

新药申请（New Drug Application，NDA）：通过三个阶段的临床试验，公司将分析所有的试验数据。

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申请

创新药物申请（NDA，New Drug Application）： III期临床试验结束后，向FDA申请的文件数以千计，大量关于临床前研究、临床研究的试验数据。

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及新药上市许可申请

...和国际上同时进行新药临床试验申请(Investigational New Drug Application，简称 IND)及新药上市许可申请(New Drug Application，简称 NDA)。

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短语

Abbreviated New Drug Application 简化新药申请 ; 简略新药申请 ; 药申请 ; 新药申请

INVESTIGATIONAL NEW DRUG APPLICATION 试验用新药申请 ; 临床研究申请 ; 新药申请 ; 新药临床试验申请

New drug application NDA 新药申请 ; 新药之由请

supplemental New Drug application 递交的补充新药上市申请 ; 新药申请 ; 补充新药申请

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医药科学

·2,447,543篇论文数据，部分数据来源于NoteExpress

abstract: The New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical for sale and marketing. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the following:

以上来源于: WordNet

UNAPPROVED:The article appears to be a new drug without an approved new drug application.

新药未经批准：此产品是新药，没有新药申请。

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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。

youdao
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。

youdao

更多双语例句

Merck and Schering-Plough filed a new drug application for Zetia with the FDA in December 2001.

FORBES: Schering-Plough And Merck's New Hope
All signals point to this being one of the best times to submit a new drug application in years.

FORBES: Why Presidents Don't Shape The FDA
After completion of more pre-clinical studies, Short hopes to file Diversa's first investigational new drug application sometime next year.

FORBES: Taking Aim At Anthrax

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