【摘 要】
：
Today eight out of every ten prescriptions (~80%) in the US are filled with generic products.Uninterrupted supply of high quality medication is in the best interest of the industry as well as our pati
【机 构】
：
Teva Pharmaceuticals
【出 处】
：
2014年中国药物制剂大会——中国药学会药剂专业委员会年会、第六届亚洲阿登制药技术研讨会暨国际控释协会中国分会年会
论文部分内容阅读
Today eight out of every ten prescriptions (~80%) in the US are filled with generic products.Uninterrupted supply of high quality medication is in the best interest of the industry as well as our patients.Recently FDA has made some significant changes to its generic drug review and approval process.These include: revision of its QbR questions to sharpen focus on QbD and control strategy, the new stability guideline, and Generic Drug User Fee Amendments (GDUFA), et al.These changes present many new challenges and opportunities.This presentation will (1) review the generic product development process and the new FDA requirements;(2) discuss how one may adopt to the new changes and excel in the very competitive generic market;(3) and use case studies to illustrate how QbD principles can be successfully applied to develop high quality generic products with robust manufacturing processes.
其他文献
目的 比较前置与上置重建钢板治疗锁骨中段复杂骨折的临床疗效.方法 回顾性分析88例闭合性锁骨中段复杂骨折采取重建钢板治疗的患者.钢板置于锁骨前方组共37例,男21例,女16例,年龄21～59岁,平均40.7岁.钢板置于锁骨上方组共51例,男38例,女13例,年龄19～62岁,平均42.5岁.随访14～35个月,平均19.3个月.对骨折愈合时间、并发症(延迟愈合、不愈合、内固定失效、肥大瘢痕)、Co
目的 分析比较锁定钢板与交锁髓内钉治疗肱骨近端骨折的治疗效果.方法 对2012年1月至2013年5月的38例肱骨近端骨折患者进行回顾性分析.根据治疗方法分为锁定钢板组(24例)与交锁髓内钉组(14例).结果 所有患者均获得随访,时间为9 ～ 23个月(平均16.1个月).两组患者在切口长度、手术时间和并发症发生率方面差异有统计学意义(t=8.857、5.323、2.460,P均＜0.05),锁定钢
目的 探讨不同内固定方法手治疗肱骨远端关节内骨折的临床疗效.方法 26例肱骨远端关节内粉碎性骨折,分别采用双钢板固定14例、单钢板结合克氏针、松质骨螺钉固定4例、"Y"形钢板内固定8例,骨折按AO/ASIF分型,B型6例,C1型9例,C2型6例,C3型5例.结果 所有26例病人均获得随访,随访时间10～22个月,平均16个月.依据Aitken和Rorabeek标准功能评定:优16例,良7例,可3例
肱骨远端C型骨折是临床上较为常见的严重肘关节损伤,属于关节内骨折.目前多主张早期切开复位内固定,重建关节面的解剖结构,恢复肱骨远端的框架结构,期望获得一个无痛且功能良好的肘关节.手术方法的正确选择直接关系到患者肘关节的功能恢复.目的 观察比较双张力带固定、双钢板垂直固定和双钢板平行固定三种内固定技术治疗肱骨远端C型骨折的临床疗效,探讨个体化治疗策略的临床意义.
Polymeric micelles represent a promising drug carrier system that has gained considerable attention due to its simplicity, small sizes (10-100 nm), and the ability to solubilize water-insoluble drugs
The combination of a rapidly dissolving and supersaturating "spring" with a precipitation retarding "parachute" has often been pursued as an effective formulation strategy for amorphous solid dispersi
The lack of safe and efficient gene delivery systems is a major obstacle to achieve successful human gene therapy.Current synthetic gene delivery systems, although safer and more versatile than natura
Gene transfer vector is one of the key technologies of gene therapy technique.Gene carriers generally can be divided into two major categories of virus and non-virus, the former is subjected to securi
In this work, two bubble-generating agents, ammonium bicarbonate (ABC) and sodium bicarbonate (SBC) that can generate CO2 bubbles, are separately encapsulated in carrier systems for actively triggerin
This presentation discusses the important role of bioequivalence (BE) study in drug product development, the adjusting of BE evaluation strategy of CDE in recent years, and common defects in BE studie