但是,我们所讨论的内部TPP并不是与食品和药物管理局(FDA)共享的TPP。术语“TPP”已被FDA采纳,主要指的是包装说明书(PI)大纲草案。(参见 fda.gov 上的指南草案,“Target Product Profile–A Strategic Development Tool”。) 该TPP本质...
药物TPP(Target Product Profile)是一个用于指导药物研发过程中的设计理念和目标的工具 3楼2023-12-16 13:28 回复 Genm-楼桑 它提供了一个明确的框架,帮助研发团队在药物研发的不同阶段确定关键的性能指标和要求,从而确保研发的药物能够满足患者和市场的需求 4楼2023-12-16 13:28 回复 Genm-楼桑 以上信...
Target product profile (TPP) in the US A TPP can be prepared by a sponsor and then shared with the appropriate FDA review staff to facilitate communication regarding a particular drug development program. Submission of a TPP is voluntary. Purpose of a TPP is to provide a format for discussion...
Target product profile: A renaissance for its definition and use - Tebbey, Rink () Citation Context .../11 $58.00+.00 漏 2011 Bentham Science Publishers Ltd.1276 Current Topics in Medicinal Chemistry, 2011, Vol. 11, No. 10 Wyatt et al. The TPP is an important strategic planning and ...
This target product profile (TPP) highlights the minimal and optimal characteristics for ex-vivo and in-vivo cell and gene therapy-based products aimed at achieving an HIV cure (ie, durable antiretroviral-free viral control). The need for an effective, safe...
Draft initial Target Product Profile (TPP) 青云英语翻译 请在下面的文本框内输入文字,然后点击开始翻译按钮进行翻译,如果您看不到结果,请重新翻译! 翻译结果1翻译结果2翻译结果3翻译结果4翻译结果5 翻译结果1复制译文编辑译文朗读译文返回顶部 草案最初的目标产品概况(TPP)...
a史密斯是一名新学生。他不是德国人,他是西班牙人。 Smith is a new student.He is not the German, he is the Spanish.[translate] aDefine and prioritize the customer needs: 定义并且给予顾客需要优先:[translate] aTemplate: Target Product Profile (TPP) 正在翻译,请等待...[translate]...
The Target Product Profile (TPP) is a tool used in industry to guide development strategies by addressing user needs and fostering effective communication ... A Ibnidris,N Liaskos,E Eldem,... - 《Journal of Translational Medicine》 被引量: 0发表: 2024年 Assessing population-level target pro...
Table S3. Scoring of target product profile comparison, for quantification of potential of candidates. Table S4. Threshold for ranking of potential at each phase of the R&D development pipeline. Additional file 2: Table S5. Candidates that met the exclusion criteria for TPP matching. Additional ...
ABSTRACT The Target Product Profi le (TPP) is supposed to be the cornerstone of pharmaceutical product development. But how often is it utilized or updated, and how closely does it resemble the product that originally was envisaged? At a ...