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- Investigational New Drug Application (IND) for the compound. 为化合物的研究中的新药物申请 (IND)。
- FDA said, companies that intend to market nicotine water should submit a new drug application to the agency for review. 食品暨药物管理局说，想要在市场上贩卖菸草水的公司，应向该局提出新的药品上市申请书，以便审核。
- Clinical trials conducted between regulatory submission of an NDA (New Drug Application) and approval of a regulatory dossier for marketing authorization. 旨在向药审机构递交了新药注册申请之后到申请药物被批准上市之前的一段时间内进行的相关药物临床试验.
- Regulatory Submissions in Electronic Format; New Drug Applications. 以电子格式递交申请:新药申请。
- It applies to the life of a drug from Investigational New Drug （IND）, New Drug Application （NDA）, post-marketing, and even removal from markedng. 方法利用文献资料采取综述的方法，介绍药品风险管理概念在美国、欧盟的发展和药品风险管理的内容。
- Clinical trials conducted between regulatory submission of an NDA( New Drug Application) and approval of a regulatory dossier for marketing authorization. 旨在向药审机构递交了新药注册申请之后到申请药物被批准上市之前的一段时间内进行的相关药物临床试验.
- Dronedarone is manufactured by Sanofi-Aventis.A new drug application was filed in June 2005 and is currently under review by the US Food and Drug Administration. 他附带表示，未来需要这2个药物互相比较的临床试验，但是这将需要非常大的试验样本。
- 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。
- Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application. 假如制药公司希望标记OTC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。
- Problems in examination of related substances in NDA file and theirs solutions were discussed in order to offer references for new drug applicants. 论述新药申报资料中有关物质检查方面存在的问题和解决办法，为新药申报者提供参考。
- For purposes of this document, the term OOS results includes all suspect results that fall outside the specifications or acceptance criteria established in new drug applications. 在本文件中，超出质量标准(OOS)结果包括所有不在新药申请中所确立的质量标准或可接受标准范围内的不可靠结果。
- ANDA Abbreviated New Drug Application 简化新药申请
- Joint Evaluation of New Drug Application 对新药申请进行联合审评
- abbreviated new drug application 新药报审简表, 新药申请审批简报
- We are testing the efficacy of a new drug. 我们正在测试新药的功效。
- The new drug has performed well in tests. 那种新药试验效果不错。
- In addition, pending new drug applications (NDA), abbreviated new drug applications (ANDA), or export approval requests may not be approved until the aforementioned deviations are corrected. 此外，还未决定的新药申请（NDA）、简略新药申请（ANDA）以及出口批准申请可能不会被批准，直到上述偏差已得到整改。
- This new drug is not yet commercially available. 这种新药还没有投放市场。
- Responsible for the development and submission of more than forty (40) successful Abbreviated New Drug Applications, (ANDAs) including “first-to-file” gabapentin capsule and tablet ANDAs. 具有27年的固体口服药品制剂的研发经验，包括10余个独特的药品缓控释放系统。
- The experiment is designed to test the new drug. 实验的目的是试验新药。
