20xx年醫(yī)學(xué)專題—開發(fā)報(bào)批美國fda的仿制藥與相關(guān)問題探討-閱讀頁
2024-11-09 12:58本頁面
【正文】 assessment of product quality QbR contains the important scientific and regulatory review questions to Comprehensively assess critical formulation and manufacturing process variables Set regulatory specifications relevant to quality Determine the level of risk associated with the manufacture and design of the product,第二十一頁，共四十一頁。,QbD小結(jié)(xiǎoji233。,研發(fā)(y225。,案例(224。)研究1 CASE STUDY 1IR Tablets,Very Low Water Solubility (低水溶性) Very Low Potency (低劑量) Micronized API used (微粉化原料藥) Wet Granulation Process (濕法制(fǎzh236。,Dissolution Profile體外溶出曲線(qūxi224。,生物(shēngw249。,原因(yu225。,案例(224。)研究2 CASE STUDY 2ER CAPSULES,No Patent (無專利(zhuānl236。,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。n l236。,UNIQUE SYSTEMCREATIVE DESIGN,Compressed Granules in Capsules Requirement Same Dissolution Behavior Uniform Yield Acceptable,第三十二頁，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。,PIVOTAL BIOSTUDY,PRODUCT P DATA (Log Transformed Data),第三十六頁，共四十一頁。n l236。,PILOT BIOSTUDY,PRODUCT DATA (Log Transformed Data),第三十八頁，共四十一頁。,謝謝(xi232。,內(nèi)容(n232。ng)總結(jié),開發(fā)報(bào)批美國FDA的仿制藥與相關(guān)(xiāngguān)問題探討。仿制藥競(jìng)爭(zhēng)的方式 HOW TO COMPETE。Coated Pellets (包衣微丸)。Tested: BA Increased。Same Dissolution Behavior,第四十一頁，共四十一
公司管理相關(guān)推薦
鄂ICP備17016276號(hào)-1