20xx年醫(yī)學專題—開發(fā)報批美國fda的仿制藥與相關(guān)問題探討-資料下載頁
2024-11-09 12:58本頁面
【正文】 Reduced Tested: BA Increased,第二十九頁，共四十一頁。,TEAM WORK,More Information Collected Analytical Support Identify the Process Used Provide the Info for Functional Coating One more Pilot and One Full BioPassed,第三十頁，共四十一頁。,案例(224。n l236。)研究3 CASE STUDY 3 ER CAPSULES,Brand Product MicroTablets in Capsules 95% of API existed in Finished Product System and Process Patented,第三十一頁，共四十一頁。,UNIQUE SYSTEMCREATIVE DESIGN,Compressed Granules in Capsules Requirement Same Dissolution Behavior Uniform Yield Acceptable,第三十二頁，共四十一頁。,SYSTEM COMPARISON,第三十三頁，共四十一頁。,PILOT BIOSTUDY,PRODUCT P DATA (Log Transformed Data, Fast, n12),第三十四頁，共四十一頁。,PILOT BIOSTUDY,PRODUCT P DATA (Log Transformed Data, FED, n11),第三十五頁，共四十一頁。,PIVOTAL BIOSTUDY,PRODUCT P DATA (Log Transformed Data),第三十六頁，共四十一頁。,案例(224。n l236。)研究4 CASE STUDY 4 ER CAPSULES,API is Water Soluble. Prototype formulation was proposed based on in vitro dissolution (OGD method).,第三十七頁，共四十一頁。,PILOT BIOSTUDY,PRODUCT DATA (Log Transformed Data),第三十八頁，共四十一頁。,Further Investigation,第三十九頁，共四十一頁。,謝謝(xi232。 xie)!,13918667400 paxhp@yahoo.com,第四十頁，共四十一頁。,內(nèi)容(n232。ir243。ng)總結(jié),開發(fā)報批美國FDA的仿制藥與相關(guān)(xiāngguān)問題探討。新藥與仿制藥NDA and ANDA。仿制藥競爭的方式 HOW TO COMPETE。End Point (Time)。Coated Pellets (包衣微丸)。Fed(Compared with Fast):。Tested: BA Increased。UNIQUE SYSTEMCREATIVE DESIGN。Same Dissolution Behavior,第四十一頁，共四十
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