FDA药品批准程序.pptx

FDA Drug Approval ProcessFDA药品批准程序;New Drug Development Process新药的研发过程;;New Drug Development Process新药研发程序;New Drug Development Process新药研发程序;;申请人(药品研发者);Generic Drug Development Process非专利药开发过程;Drug Application 药品申请;Bioavailability (BA) 生物有效性;Bioequivalence (BE) 生物等效性;Generic Drug 非专利药;Generic Drug Requirement非专利药要求;Type of ANDA 非专利药申请的分类;2002 年全球药品销售分析;2003-2004 年全球药品销售分析;Worldwide Pharmaceutical Market by Sectors ($ Billions)世界药品市场分类（单位：十亿美元）;Top 10 Therapies10大类药物;Top 10 Products (2003-2004)10大药品（2003－2004）;Drugs off U.S. Patent by 2007截至2007年美国专利到期的药品;Chemistry, Manufacturing and Controls (CMC)化学性、生产和控制（CMC）;Drug Master File (DMF) 药物主文件（DMF）;Drug Master File (DMF)药物主文件（DMF）;CGMP Inspection ProcessCGMP检查程序;CGMP Inspection ProcessCGMP检查程序;CGMP Regulation Guideline有关 CGMP 的文件 ;System Based Current Good Manufacturing Practice (CGMP) 基于CGMP的系统;DMF PreparationDMF文件的准备;Drug Substance (API)原料药（API）;Drug Substance (API)原料药（API）;Summary总结;随时欢迎客户的任何新的和更深入的探讨;9、春去春又回，新桃换旧符。在那桃花盛开的地方，在这醉人芬芳的季节，愿你生活像春天一样阳光，心情像桃花一样美丽，日子像桃子一样甜蜜。5月-215月-21Monday, May 31, 2021 10、人的志向通常和他们的能力成正比例。13:50:1713:50:1713:505/31/2021 1:50:17 PM 11、夫学须志也，才须学也，非学无以广才，非志无以成学。5月-2113:50:1713:50May-2131-May-21 12、越是无能的人，越喜欢挑剔别人的错儿。13:50:1713:50:1713:50Monday, May 31, 2021 13、志不立，天下无可成之事。5月-215月-2113:50:1713:50:17May 31, 2021 14、Thank you very much for taking me with you on that splendid outing to London. It was the first time that I had seen the Tower or any of the other famous sights. If Id gone alone, I couldnt have seen nearly as much, because I wouldnt have known my way about. 。31 五月 20211:50:17 下午13:50:175月-21 15、会当凌绝顶，一览众山小。五月 211:50 下午5月-2113:50May 31, 2021 16、如果一个人不知道他要驶向哪头，那么任何风都不是顺风。2021/5/31 13:50:1713:50:1731 May 2021 17、一个人如果不到最高峰，他就没有片刻的安宁，他也就不会感到生命的恬静和光荣。1:50:17 下午1:50 下午13:50:175月-21