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kk444555 在 2023-10-17 22:57 回答了问题 EMA: How can a design space beverified at commercial scale?; kk444555: It is not necessary to repeat at commercialscale the experiments initially conducted to define a design space at labor pilotscale. Furthermore, it is ...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:56 回答了问题 EMA: How is a design space initiallydeveloped and verified at commercial scale?; kk444555: Both Agencies acknowledge that when adesign space is established at early stages of product development, it istypically developed based on experiments...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:56 回答了问题 EMA: What is the purpose of design spaceverification at commercial scale?; kk444555: Design space verification demonstrates thatwithin design space boundaries scale-up effects are under control and do notadversely affect the expected p...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:54 回答了问题 EMA: Why would a design space beverified during the product lifecycle?; kk444555: In both Agencies’ experience, the designspace verification at commercial scale is not necessarilycomplete at the time of submission of the application...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:53 回答了问题 EMA: 在临床药品（IMP）开发阶段整个过程中是否要对HBEL进行重新评估？; kk444555: Health-Based Exposure Limits should be established based on all available data, and particularly as the knowledge base for IMPs is continually evolvin...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:52 回答了问题 EMA: 在同一设施中生产不同物种的兽药时要考虑什么？; kk444555: The guideline on setting health-based exposure limits indicates that the carry over limit should generally be derived using the human HBEL.HBEL设定指南指出一...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:52 回答了问题 EMA: 杀外寄生虫药物是否可以与其它类别人用或兽用药品在共用设备中生产或进行内包装？; kk444555: If a HBEL cannot be determined or data cannot support manufacture in shared facilities then the Ectoparasiticides should be manufactured in dedicated ...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:51 回答了问题 EMA: Is the use of LD50 to determine Health-Based Exposure Limits for drug products acceptable?; kk444555: No, LD50 is not an adequate point of departure to determine a HBEL for drug products.不可以，LD50用于计算药品HBEL是不充分的。; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:50 回答了问题 EMA: 简单地在专用区内生产同一类治疗用途的药品进行分隔作为交叉污染风险控制方式是否可接受？; kk444555: Manufacturers cannot just segregate common products from other product types as a means of dealing with the risk to patient and animal safety. A...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:49 回答了问题 EMA: What are the requirements for conducting visual inspection as per Q&A 7?; kk444555: When applying visual inspection to determine cleanliness of equipment, manufacturers should establish the threshold at which the product is readily vi...; 赞同0 反对 0 人感谢 0 评论 1 回复

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