SECT 505(b)(2)的意思
「SECT 505(b)(2)」經常作為「New drug application」的縮寫來使用,中文意思:「新藥申請」。
SECT 505(b)(2)(新藥申請)詳細解釋
- 英文縮寫詞:SECT 505(b)(2)
- 英文單詞:New drug application
- 中文簡要解釋:新藥申請
- 分類:Governmental
- 領域:FDA
英文縮寫SECT 505(b)(2)的擴展資料
- AIM : To introduce the concept of bridging study and its strategies in clinical trials for new drug application.目的:介紹新藥臨床試驗中橋接試驗的概念和實施策略。
- This platform is composed by GRP experiment management system, GLP new drug application system and drug discovery standard workflow management system.該平臺由GRP實驗管理系統、GLP新藥申報系統和新藥研發標準化流程管理系統組成。
- UNAPPROVED : The article appears to be a new drug without an approved new drug application.新藥未經批準:此產品是新藥,沒有新藥申請(SECT 505(b)(2))。
- Research in Profile of Chemical Investigational New Drug Application in China創新性化學藥品在中國的申報狀況研究
- Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application.如果制藥公司希望標記OTC但沒有達到專著要求的,均可以提交新藥上市的申請和獲得注冊新藥的許可。