相比FDA，WHO更早地提出了新冠病毒疫苗目标产品的指南，而且细致到了功效标准、接种程序、保护持续时间等多个方面。此前4月9日，WHO发布的新冠病毒疫苗的目标产品简介（target product profile），基于专家在新冠病毒创新论坛的讨论，列出了WHO对新冠病毒疫苗产品的多项指标希望达到、最低限度应该达到的标准。WHO同时在...
世界卫生组织(WHO)在今年 2 月召开的新冠病毒创新论坛上就召集了来自世界各地的专家,共同探讨新冠病毒疫苗产品应该具有的特征。4 月 9 日,WHO 发布了新冠病毒疫苗的目标产品简介(target product profile),基于专家在新冠病毒创新论坛的讨论,这一文件列出了 WHO 对新冠病毒疫苗产品的多项指标希望达到和最低限度应该达...
A WHO target product profile document presents a need and provides guidance on what to include to consider access and equity as part of the research and development plan from the outset. WHO has also set up the Target Product Profile Directory, a free-to-use online database o...
12.16. The quality target product profile, critical qualityattributes, critical process parameters, material attributes, control strategyand any other impacting elements on the quality of the product should beavailable. (See also ICH guidelines.) 质量目标产品概况、关键质量属性、关键工艺参数、原料属性、控...
相比FDA,WHO更早地提出了新冠病毒疫苗目标产品的指南,而且细致到了功效标准、接种程序、保护持续时间等多个方面。此前4月9日,WHO发布的新冠病毒疫苗的目标产品简介(target product profile),基于专家在新冠病毒创新论坛的讨论,列出了WHO对新冠病毒疫苗产品的多项指标希望达到、最低限度应该达到的标准。 WHO同时在文件中...
12.15. Product, process and procedure knowledge should be an essential part of the transfer process from SU to RU. 产品、工艺和程序知识应该是从SU到RU的转移的重要组成部分。 12.16. The quality target product profile, critical quality attributes, critical process parameters, material attributes, control...
12.16. The quality target product profile, critical quality attributes, critical process parameters, material attributes, control strategy and any other impacting elements on the quality of the product should be available. (See also ICH guid...
12.15. Product, process and procedure knowledge should be an essential part of the transfer process from SU to RU. 产品、工艺和程序知识应该是从SU到RU的转移的重要组成部分。 12.16. The quality target product profile, critical quality attributes, critical process parameters, material attributes, control...
产品质量目标档案(QualityTargetProductProfile,QTPP):一种预先做出的药品质量特性概要,它综合考虑药品的安全性和有效性,并在理论上能够确保药品符合预期的质量要求。质量目标产品档案构成药品研发的设计基础。质量目标产品档案主要考虑以下方面: 临床设置,用药途径,剂型,运转系统; 剂量强度; 密封系统; 疗效成分的释放或...
(AA) sequence of the protein which is the relevant target for IgE. However, criteria for acceptance of sequences to the database have been adjusted over time as methods of protein determination have improved. A few new allergens were identified in a 1995 WHO/IUIS update (King et al., ...