【摘 要】
：
Quality consistency evaluation is a comprehensive and systematic system to confirm the pharmaceutical and clinical consistency between generic preparation a
【出 处】
：
第二届全国生物颗粒学术研讨会、第三届国际工业药学和临床药学研讨会暨第一届岭南国际药学大会
论文部分内容阅读
Quality consistency evaluation is a comprehensive and systematic system to confirm the pharmaceutical and clinical consistency between generic preparation and reference preparation.The consistency evaluation is a popular practice in the international drug research.The consistency evaluation in China began since 2012, and the measures of awards and punishment were issued at September 18, 2015 to accelerate the development of consistency evaluation.The focuses of the pharmaceutical consistency evaluation were consistency of dissolution and related substances.The bioequivalence is the key point in the clinical consistency of generic preparation.In the R&D, the importance of reference preparation selection, the crystal form and particle size of API and the dissolution or release method will be illustrated in this report.
其他文献
Objective This study was to prepare and characterize a novel redox-sensitive system which was modified by SWCNTs-HA carrying both anticancer drug, doxorubic
Objective Mechanical ventilation (MV) has become an important clinical treatment of acute and severe patients, however ventilator induced lung injury (VILI)
Poly (D, L-lactic-co-glycolic acid) (PLGA) is being an increasing extensive material to apply in the long-acting drug delivery system.Currently the most ado
Traditional therapy aimed at changing tumor microenvironment makes efforts on reducing tumor vessel density to control its growth.However, starving therapy
本研究利用超临界流体色谱技术对三种构型的维生素E的混合物进行定性分析和制备分离.分离VE混合物的研究中,主流动相为超临界二氧化碳,携带剂为甲醇、乙醇,色谱柱为硅胶柱、O
FGFR（成纤维细胞生长因子受体）及其配体FGF在调控细胞的增殖、分化、转移过程中起重要作用，当其发生基因扩增、激活突变、染色体易位时，FGFR过度激活，促进癌细胞的增殖、纤维化、
该文介绍了生产润滑油基础油的加氢技术类型和工艺路线,对国内外基础油加氢技术进行了比较分析.并针对茂名石化公司石蜡基原油短缺而中东原油加工量急剧增加的现状,国际润滑
The drug-loaded self-double-emulsifying drug delivery system (SDEDDS) was prepared, and its preliminary pharmacodynamics was investigated.The type and conce
层状富锂锰基正极材料xLi2MnO3·(1-x)LiMO2(M=Ni，Co，Mn)具有高比容量、高电压和成本低等特点，是应用于下一代高性能锂离子电池的候选正极材料之一。但富锂锰基正极材料较低的首
本论文采用钙钛矿晶格氧催化剂作为氧源,在无气相氧的条件下,利用钙钛矿中的变价金属的氧化-还原特性,直接将甲烷选择性氧化成合成气的新工艺.在实验室的前期工作中,探讨了钙