Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry guidanceUSFDAANVISAMHLWEMAThe concepts, importance, and application of bioanalytical method validation have been discussed for a long time and validation of ... Naveen,Kadian,Kanumuri,... - 《Journal of Pharma...
各國DMF制度管理介紹一USFDADMF制度介紹.pdf,各國 DMF 制度管理介紹 藥劑科技組 盧可禎 Drug Master File(簡稱 DMF)為原料藥主檔案,是一套反映原料藥生產與品質管制的 完整資料,包含生產廠、製程、規格、檢驗方法及安定性等方面的內容。不同國家及地 區對申請方式與 DMF的
申請者或生產商應遵循以下 Guidelines: Guidance for Industry M4Q:The CTD-Quality Draft Guidance for Industry Submitting Marketing Applications According to the ICH-CTD Format —General Considerations. Guideline for Submitting Documentation for the Manufacture of and Controls for Drug Products Guide...
(USFDA, WHO& ASEAN) Results: After pooling all the information and data that was collected in duecourse of time of the research, was made into comparative chart format where it is shown thatamong group of countries (like WHO, ASEAN) and also these guidelines were comparedwith regulated ...