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...
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, 如“图11”所示进行精确检索或模糊检索。 图11 以“BALSAM PERU”为例,在“图11”中精确检索栏输入“BALSAM PERU”输入,检索,弹出检索的信息,如“图12”。
参考文献（可上下滑动）：1.https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 2.https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2023-biological-license-application-approvals 3.https:/...
Current Location:Home>FDA Approved Drug ProductsFeedbackHelp Show All Show Application NumberApplication TypeDrug NameActive IngredientsDosage Form/RouteApproval DateCompany 761449BLATYENNETOCILIZUMAB-AAZGINJECTABLE;INJECTIONFRESENIUS KABI USA 761429BLAOPDIVO QVANTIGNIVOLUMAB;HYALURONIDASE-NVHYINJECTABLE;INJ...
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 (...
橙皮书(Approved Drug Products,电子版) 应该说,这是FDA网站的涉及药学最精华部分,是国内新药研究工作者、特别是把握国内外药学进展的智囊们最关心的部分。该栏目更新很快,且系统、权威而全面。进入橙皮书网页后,可以根据4个线索来查寻(活性成份、专有名、申请人、申请号),以点击“...
1.https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 2.https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2023-biological-license-application-a...
1.https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 2.https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2023-biological-license-application-approvals ...
1、Bioequivalence (BE) Recommendations forSpecific Products: 提供具体品种的生物等效性试验建议,为ANDA申报提供支持。 按照活性成分字母排序,搜索简单方便。目前已收录1397个品种的BE建议。 2. Inactive Ingredient Search for Approved DrugProducts: FDA批准药物所使用的非活性成分数据库,即FDA上市产品中包含的辅料信息...
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 (MDE...