new drug application 中文意思是什麼

new drug application 解釋
新藥上市申請,注冊新藥
  • new : NEW ＝net economic welfare 〈美國〉純經濟福利。adj 1 新的，嶄新的；新發現的，新發明的；新開發的。...
  • drug : n 1 藥，藥品，藥物，藥劑。2 〈俚語〉麻醉藥品，麻醉劑，使人上癮的毒品 （＝narcotic drugs）。3 〈pl...
  • application : n. 1. 適用，應用；運用。2. 申請，請求；申請表格。3. 勤勉，用功。4. 敷用；敷用藥。
  1. 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。
  2. The application of a new cornea dressing material called irradiated drug containing xeno cornea in the rehabilitation of ocular burns

    新型角膜覆蓋材料含藥輻照異種角膜在眼燒傷康復中的應用
  3. This research began with detecting the rpob gene mutations of 37 mycobacterium tuberculosis clinical isolates by polymerase chain reaction - single strand conformation polymorphism ( pcr - sscp ) to study the application value of this method as a new molecule testing method for drug susceptibility

    本研究首先通過聚合酶鏈反應?單鏈構象多態性分析技術對37株結核分枝桿菌臨床分離株的rpob基因進行突變檢測，目的在於探討pcr - sscp作為新的分子藥敏試驗方法的應用價值。
  4. 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
  5. Fda is working with the manufacturers of pergolide to determine if it might be possible, once the drug is withdrawn from the market, to make the drug aailable under an inestigational new drug application ( ind ) for those few patients who are currently receiing pergolide and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。
  6. However, the lack of a simple, sensitive, and reliable method for mersuring mt has been an obstacle to the elucidation of its physiological and pathological role [ 3 - 5 ]. after initial attempts with bioassay, gas chromatography - mass spectrometry for quantifying mt in body fluids was tried, followed by hplc. the major limitations to these techniques were expense, low throughput, extensive sample work - up before assay [ 4, 5 ]. in order to further study the funcation of pineal gland, also in order to deeper understand drug - receptor interactions, therefore better to build mt receptor models and to design new seletive ligands. which applying solid foundation for mt and its analoges ' s therapeutical application. we produce and characterizate monoclonal antibodies to melatonin

    Kx碩士掌位論文wmaster 』 stiffisis在最初嘗試用生物檢測法、氣相色譜一質譜來檢測mt在體液中的量，后來通過高效液相色譜6 8 ，這些技術主要的限制是過于昂貴檢測樣品少、檢測前樣品處理復雜3 ， 4 。為了更進一步地研究松果體的功能，也為更深入了解藥物受體的內在反應，為建立更完善的mt受體模型和設計新的可選性配體，為mt和其類似物治療應用提供堅實的基礎，我們制備和鑒定了抗mt的單克隆抗體。
  7. Application of medical ethical education in new drug evaluation teaching plays an significant role in the cultivation of good style of scientific research, promotion of morality, construction of cooperative spirits and selfregulation of the thoughts, behaviors and souls for medical students

    寓醫學科研道德教育于課程教學中，可培養學生良好的科研作風，提高道德素養，樹立團結協作精神並規范自己的思想、品行和情操。
  8. It has important scientific significance and application value if the research project will be implemented, because it is propitious to understand structure - function relationship, prevent and cure some related diseases, comprehend the regulation mechanism of inorganic molecules to biological reactions, discover new target molecules of drug action, design and develop medicines

    這對于?解生物大分子的結構、功能，對于疾病預防和治療， ?解小分子對生命過程的調控機制，對于藥物作用新靶點的發現、藥物的分子設計、作用機理和藥物的研究與開發，均具有十分重要的科學意義和應用價值。
  9. Investigational new drug application

    即新藥臨床試驗申請
  10. The requirements of dossier contents for licensing application are different in u. s. a, eu and china. this dissertation explains the dossier detailedly include : the dossier requirements of veterinary domestic, import product and animal drug product in u. s. a. the dossier requirements of immunological medical product, medicine product and unimmunological medical product in eu. and chinese dossier requirement of domestic new veterinary biological and drug product, import eterinary biological and drug product

    本文詳細介紹了美國獸用生物製品中國內產品和進口產品的注冊申報材料及獸用藥品的材料要求；介紹了歐盟對免疫用獸醫藥品和獸醫藥品、非免疫用獸醫藥品的書寫格式和內容的要求；同時詳細說明了中國對申報國內新獸用生物製品和新獸藥、進口獸用生物製品和獸藥的注冊申報材料的項目要求。
  11. New drug application

    及新藥上市許可申請
  12. 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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