新藥申請 的英文怎麼說

中文拼音 [xīnyàoshēnqǐng]
新藥申請 英文
new drug a lication， nda
  • 新 : Ⅰ形容詞1 （剛出現的或剛經驗到的） new; fresh; novel; up to date 2 （沒有用過的） unused; new 3 （...
  • 藥 : Ⅰ名詞1 （藥物） medicine; drug; remedy 2 （某些有化學作用的物質） certain chemicals Ⅱ動詞1 [書面...
  • 申 : Ⅰ動詞（說明; 陳述） state; express; explain Ⅱ名詞1 （地支的第九位） the ninth of the twelve earth...
  • 請 : 動詞1. （請求） request; ask 2. （邀請; 聘請） invite; engage 3. （招待; 款待） entertain 4. [敬] （用於希望對方做某事） please
  • 申請 : apply for; ask for
  1. The application of automatic mix subsystem and dosing subsystem adopting new techniques makes the investment of chemical dosing system and operating cost decrease greatly. now, this two measure methods have been patented

    採用新技術的自動配液子系統和自動投加子系統在生產中應用，使得水廠藥液配投系統投資和運行費用大幅降低，這兩種計量方式已經申請專利。
  2. If ha has switched from its previous policy of bearing most of the expenses for first - line drugs to arranging for the expenses of the existing and new first - line drugs to be subsidised by charity funds, and to conducting income and asset tests on the subsidy applicants

    （三）醫管局是否已改變過往提供第一線藥物的大部分費用的政策，並改為安排由慈善基金津貼現有及新增的第一線藥物的費用，以及審查有關津貼申請人的入息和資產？
  3. An application for human testing of a new drug is expected to be filed by the end of 2006

    在中長期新藥研發方面也進展的相當順利，預計在2006年底可以申請新藥人體試驗。
  4. She was also the winner of a third grade prize from the ministry of public health on " the use of 86rb for determining coronary blood flow in the mice ". she has published more than 60 original peer reviewed scientific papers, and contributing in more than 10 books, including " drug metabolism ", " modern pharmacology ", " the application of isotope technique in biological medicine " first grade national prize, " the modern research in traditional chinese medicine " first grade prize from the ministry of public health, etc

    該品在臨床應用20多年，取得了良好的效益。九十年代，他用梔子果實替代價昂貨缺的番紅花，成功地提取西紅花甙，並製成片劑新藥中藥二類，即將上市。多年的基礎和應用研究，他先後發表50餘篇論文，申請國家發明專利1項。
  5. 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 ） 、簡略新藥申請（ anda ）以及出口批準申請可能不會被批準，直到上述偏差已得到整改。
  6. Abstract : starting with the examinational procedure and technique specification of new drug license application in china andusa, the differences between two countries in definition of new drug and its classification, clinical study and the new drug license application are compared. development trend of international examinational system and some relevant countermeasures of china are introduced. also, scientific progress of china ' s regulations of application in new drug license to approach the international standard are analyzed

    文摘:從中美兩國新藥審批程序和技術要求入手，對新藥的定義、分類、審批程序、新藥臨床研究申請和新藥申請等方面的異同進行了比較和客觀評析，介紹了國際新藥審評制度發展新動向和我國新藥審批辦法的若干改革舉措，分析了我國新藥審批辦法與國際接軌的科學化進程
  7. Fda is working with the manufacturers of pergolide to determine if it might be possible, once the drug is withdrawn from the market, to make the drug aailable under an inestigational new drug application ( ind ) for those few patients who are currently receiing pergolide and who cannot be successfully conerted to other aailable treatments

    Fda正在與培高利特生產廠商進行協商，一旦該藥撤市后，對于那些少數目前正在使用該藥而不能成功改換其他藥物治療的患者，是否可在「試驗新藥申請」許可下進行使用該藥的可能性。
  8. He is the author of scores of papers and articles on various intellectual property law subjects and a frequent speaker on many ip - related topics at seminars and conferences hold by chinese government organs at different levels. he then established beijing huize intellectual property law llc in 1995 the former is beijing huize patent trademark agency. he has successfully acted as an agent for more than 1600 patent applications, more than 200 cases of patent invalidation and more than 350 patent infringement litigations

    1995年發起創辦了北京匯澤知識產權代理有限公司初始名稱為北京匯澤專利商標事務所，代理機械類專利申請1600餘件專利無效案件200餘件，代理專利侵權訴訟350餘件，其中代理的深圳萬基集團訴他人外觀設計專利無效案滑板車專利侵權案江蘇南風集團上海太平洋化工集團有限公司訴他人發明專利無效及行政訴訟案皇家菲利浦電子公司燈具侵權打假案天旗體育用品寧波有限公司訴實用新型專利無效及行政訴訟案北京曲美家具有限公司專利侵權訴訟案方太集團被訴專利無效案中國首件中藥專利無效案等均屬國內知名知識產權案件。
  9. These products do not require an nda

    這些產品不必需要新藥上市申請。
  10. A group of 18 leading european pharmaceutical companies and clinical research organisations backed the scrapping of “ acute toxicity tests ”, which have long been conducted in rodents to identify the minimal lethal dose of an experimental drug while universally applied in the past to win regulatory approval, the companies concluded that the tests, first introduced in 1927, had been superseded by others that were more accurate and were therefore no longer needed as a precondition for launching drug tests in humans

    18家有影響的歐洲制藥公司和臨床研究組織支持廢棄"急性毒性試驗" ，長期以來，在急性毒性試驗中，嚙齒類動物被用於確認實驗性藥物的最小致死量在過去，急性毒性試驗普遍用於申請新藥試驗許可，公司認為1927年發明的試驗方法，現在可以由其它更加準確的方法代替，因此不再作為新藥測試的必要前提。
  11. Assist senior registration manager for the applications for new drug products, variations of marketed products and license renewals within the set timeframe and conducting in compliance with local regulatory agency requirements as well as relevant pfizer sop

    協助注冊經理進行新產品注冊、已上市產品的?更及換證申請工作，確保每個項目運作符合我國相關藥品管理辦法及輝瑞公司的標準操作程序，在規定的時間內及時地完成。
  12. It is worth mentioning that the intellectual property protection scheme of china has been well developed to meet the demand of the potentially largest pharmaceuticals market within a comparatively short period of time. for numerous reasons, primarily difficulties in construing the prevailing rules, companies do have problems, in particular, with patent application, conviction of infringement, the relationship between administrative protection and registration of innovative pharmaceuticals, and adjustment to marketing strategies. the dissertation analyzes the problems and recommends solutions ranging from extension of patent lives through new formulations to competent ip attorneys

    然而，由於各種原因，在企業尋求藥品知識產權保護的過程中也存在著一些問題，比如在藥品專利的申請、侵權行為的構成、新藥保護制度與行政保護制度的關系、以及如何根據我國藥品知識產權保護制度的特點制訂營銷策略方面就存在著一些誤區，如認為任何模仿行為都是專利侵權行，或者傾向于以公關手段解決法律問題等，甚至有些企業還認為我國的新藥保護制度違背了中國關于藥品行政保護做出的承諾。
  13. At present, the agency generally undertakes such analyses only when drug makers seek to win approal for a new use of a medicine, he said

    他說，目前行政部門通常僅在藥品生產商試圖申請藥品新用途時才進行這種分析。
  14. Investigational new drug application

    即新藥臨床試驗申請
  15. New drug application

    及新藥上市許可申請
  16. 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後到申請藥物被批準上市之前的一段時間內進行的相關藥物臨床試驗
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