i. Invitro release of the drug substance from the liposome drug product under the stated/described experimental conditions with supportive data and information regarding the choice of those conditions. 在陈述/描述的实验条件下,进行脂质体药品的体外释放...
Introduction to the guidance for industry on liposome drug products:chemistry,manufacturing,and controls; human pharmacokinetics and bioavailability; and labeling documentation issued by FDA 导读 周誉,宫新江,杨进波 国家药品监督管理局药品审评中心 摘要 美国食品药品监督管理局( FDA) 于2018 年4 月发布了《...
fda脂质体指导原则中英文对照 Liposome Drug Products Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this ...
[9] FDA. Guidance for Industry Liposome Drug Products: Chemistry, Manufacturing, and Controls, Human Pharmacokinetics and Bioavailability, and Labeling Documentation [EB/OL]. (2018-04-05) [2023-02-06]. https://www.fda.gov/media/70837/download. [10] FDA. Guidance for Industry and FDA Staff...
本指南取代了2002年发布的原行业指南草案Liposome Drug Products, Chemistry, Manufacturing, and Controls;...
2024年2月13日,FDA批准了Ipsen Biopharmaceuticals开发的Onivyde(liposome)与奥沙利铂、氟尿嘧啶和亚叶酸联合,用于转移性胰腺癌的一线治疗。 AURLUMYN 2024年2月14日,FDA批准了Eicos Sciences开发的 Aurlumyn(iloprost)注射液用于治疗成人严重冻伤,以降低手指或脚趾截肢的风险。这项批准首次为患者提供了治疗严重冻伤的...
2024年2月13日,FDA批准了Ipsen Biopharmaceuticals开发的Onivyde(liposome)与奥沙利铂、氟尿嘧啶和亚叶酸联合,用于转移性胰腺癌的一线治疗。 AURLUMYN 2024年2月14日,FDA批准了Eicos Sciences开发的 Aurlumyn(iloprost)注射液用于治疗成人严重冻伤,以降低手指或脚趾截肢的风险。这项批准首次为患者提供了治疗严重冻伤的...
Liposome Drug Products:Chemistry,Manufacturing,and Controls;Human Pharmacokinetics and Bioavai labi l ity;and Label ing Documentation (I) 8/21/2002 Metered Dose Inhalers(MDI)and Dry Powder Inhalers(DPI)Drug Products(I) 1 1/19/1998 Non-Penici l l inBeta-Lactam RiskAssessment:ACGMPFramework ...
the GDUFA (Generic Drug User Fee Amendments) funded research on nanotechnology products, FDA is committed to performing research (internal and extramural) on topics related to quality assessment for ANDAs for complex drugs such as iron-gluconate and several issues related to liposome characterization. ...
Preparation and characterization of gemcitabine liposome injections. In this study, since extrusion technology was used to make sterile preparation of liposomes, the process included aseptic production process and sterile ... Q Zhou,L Liu,D Zhang,... - 《Die Pharmazie》 被引量: 30发表: 2012年 ...