您要查找的是不是：
- Clinical trials conducted between regulatory submission of an NDA (New Drug Application) and approval of a regulatory dossier for marketing authorization. 旨在向藥審機構遞交了新藥注冊申請之后到申請藥物被批準上市之前的一段時(shí)間內進(jìn)行的相關(guān)藥物臨床試驗.
- It applies to the life of a drug from Investigational New Drug （IND）, New Drug Application （NDA）, post-marketing, and even removal from markedng. 方法利用文獻資料采取綜述的方法，介紹藥品風(fēng)險管理概念在美國、歐盟的發(fā)展和藥品風(fēng)險管理的內容。
- Clinical trials conducted between regulatory submission of an NDA( New Drug Application) and approval of a regulatory dossier for marketing authorization. 旨在向藥審機構遞交了新藥注冊申請之后到申請藥物被批準上市之前的一段時(shí)間內進(jìn)行的相關(guān)藥物臨床試驗.
- 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. 這個(gè)過(guò)程允許公司提交的新藥申請（NDA），因為它們變得可用，而不是提出在一旦所有的部分章節。
- Investigational New Drug Application (IND) for the compound. 為化合物的研究中的新藥物申請 (IND)。
- Problems in examination of related substances in NDA file and theirs solutions were discussed in order to offer references for new drug applicants. 論述新藥申報資料中有關(guān)物質(zhì)檢查方面存在的問(wèn)題和解決辦法，為新藥申報者提供參考。
- FDA said, companies that intend to market nicotine water should submit a new drug application to the agency for review. 食品暨藥物管理局說(shuō)，想要在市場(chǎng)上販賣(mài)菸草水的公司，應向該局提出新的藥品上市申請書(shū)，以便審核。
- 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，還未決定的新藥申請（NDA）、簡(jiǎn)略新藥申請（ANDA）以及出口批準申請可能不會(huì )被批準，直到上述偏差已得到整改。
- Regulatory Submissions in Electronic Format; New Drug Applications. 以電子格式遞交申請:新藥申請。
- 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. 他附帶表示，未來(lái)需要這2個(gè)藥物互相比較的臨床試驗，但是這將需要非常大的試驗樣本。
- Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application. 假如制藥公司希望標記OTC但沒(méi)有達到專(zhuān)著(zhù)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。
- 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，超出質(zhì)量標準(OOS)結果包括所有不在新藥申請中所確立的質(zhì)量標準或可接受標準范圍內的不可靠結果。
- ANDA Abbreviated New Drug Application 簡(jiǎn)化新藥申請
- We are testing the efficacy of a new drug. 我們正在測試新藥的功效。
- Joint Evaluation of New Drug Application 對新藥申請進(jìn)行聯(lián)合審評
- abbreviated new drug application 新藥報審簡(jiǎn)表, 新藥申請審批簡(jiǎn)報
- The new drug has performed well in tests. 那種新藥試驗效果不錯。
- This new drug is not yet commercially available. 這種新藥還沒(méi)有投放市場(chǎng)。
- The experiment is designed to test the new drug. 實(shí)驗的目的是試驗新藥。
- They are injecting him with a new drug. 他們正為他注射新藥。
