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。

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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。

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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。

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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

The gamble paid off, as Merck was able to file a new-drug application six weeks before Novartis.

FORBES: Health

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