20xx年醫(yī)學(xué)專題—開發(fā)報批美國fda的仿制藥與相關(guān)問題探討(參考版)
2024-11-09 12:58本頁面
【正文】 ,。UNIQUE SYSTEMCREATIVE DESIGN。Fed(Compared with Fast):。End Point (Time)。新藥與仿制藥NDA and ANDA。ir243。 xie)!,13918667400 paxhpyahoo.com,第四十頁，共四十一頁。,Further Investigation,第三十九頁，共四十一頁。)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。,案例(224。,PILOT BIOSTUDY,PRODUCT P DATA (Log Transformed Data, FED, n11),第三十五頁，共四十一頁。,SYSTEM COMPARISON,第三十三頁，共四十一頁。)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。,案例(224。)) Coated Pellets (包衣微丸) 1st Bio Study Failed Fast: Close Fed(Compared with Fast): Brand: BA Reduced Tested: BA Increased,第二十九頁，共四十一頁。n l236。nyīn)調(diào)查,第二十八頁，共四十一頁。)等效(BE)結(jié)果,Summary of in vivo study results of Test Formulation vs. RLD,第二十七頁，共四十一頁。n),第二十六頁，共四十一頁。)粒),第二十五頁，共四十一頁。n l236。n fā)(高難)仿制藥的一些體會,第二十四頁，共四十一頁。)SUMMARY,第二十三頁，共四十一頁。,Examples of QbD questions under QbR ? Control of Drug Substance – What is the drug substance specification? Does it include all the critical drug substance attributes that affect the manufacturing and quality of the drug product? (2 pages) ? Drug Product – What attributes should the drug product possess? (1.5 pages) – How were the excipients and their grades selected? – How was the final formulati
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