点击“图9”中“Printable List of All Drugs in the Database”,进入模糊查找页,可点击“图10”中“EXCEL”下载全部药物溶出方法,方便离线检索。 图10 3、非活性成分数据库及行业指导原则 点击“图3”中“Inactive Ingredient Search for Approved Drug Products Search...
2.4 Inactive Ingredient Search for Approved Drug Products Search（被批准药物的非活性成分数据库）点击“图3”中“Inactive Ingredient Search for Approved Drug Products Search”进入非活性成分数据库进行检索。▲ 图-17 以“Lactose”为例，可获得该辅料的Maximum Potency per unit dose和Maximum daily exposure...
点击“图9”中“Printable List of All Drugs in the Database”,进入模糊查找页,可点击“图10”中“EXCEL”下载全部药物溶出方法,方便离线检索。 图10 3、非活性成分数据库及行业指导原则 点击“图3”中“Inactive Ingredient Search for Approved Drug Products Search”进入非活性数据库检索页,网址:网页链接, ...
点击上图中“Printable List of All Drugs in the Database”,进入模糊查找页,点击“EXCEL”下载全部药物溶出方法,方便离线检索。 3.非活性成分数据库 点击“导航页”中“Inactive Ingredient Search for Approved Drug Products Search”进入非活性数据库检索页,搜索框可以进行精确检索或模糊检索。 网址:https://www...
“Form & Submission Requirements” →Drug Master Files (DMFs) →Types of DMFs→Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product,或者直接输入网址:fda.gov/drugs/drug-mast,找到List of Type II DMFs Available for Reference后点击即可获得DMF...
There are Drug products approved by the U.S. Food and Drug Administration Abbreviations: A/ANDA: Abbreviated New Drug Application Discn: discontinued Drugs N/NDA: New Drug Application, OTC: Over the Counter RLD: reference listed drug Rx: Prescription Drug TE: Therapeutic Equivalence Code, NDA: ...
2.4 Inactive Ingredient Search for Approved Drug Products Search(被批准药物的非活性成分数据库) 点击“图3”中“Inactive Ingredient Search for Approved Drug Products Search”进入非活性成分数据库进行检索。 ▲图-17 以“Lactose”为例,可获得该辅料的Maximum Potency per unit dose和Maximum daily exposure (...
点击“图9”中“Printable List of All Drugs in the Database”,进入模糊查找页,可点击“图10”中“EXCEL”下载全部药物溶出方法,方便离线检索。 图10 3、非活性成分数据库及行业指导原则 点击“图3”中“Inactive Ingredient Search for Approved Drug Products Search”进入非活性数据库检索页,网址:accessdata....
Pawar, Vinay GorakhnathPost, PharmdCandidate, Baccalaureate
Approved Risk Evaluation and Mitigation Strategies (REMS):批准的风险评估和缓解策略(REMS) Bioresearch Monitoring Information System (BMIS) Search:生物研究监测信息系统(BMIS)搜索 Clinical Investigator Inspection List (CLIIL) Search:临床研究者检查名单(CLIIL)搜索 ...