20150225 ECA新闻：关于法规申报资料中的DOE相关详细要求：EMA和FDA建议

20150225 ECA新闻：关于法规申报资料中的DOE相关详细要求：EMA和FDA建议  

2015-02-27 20:10:30|  分类： ECA新闻|

GMP News
25/02/2015

http://www.gmp-compliance.org/enews_04652_Detailed-Requirements-concerning-the-DOE-in-the-Regulatory-Submission-Dossier-EMA--39-s-and-FDA--39-s-Recommendations.html

Detailed Requirements concerning the DOE in the Regulatory Submission Dossier: EMA's and FDA's Recommendations

关于法规申报资料中的DOE相关详细要求：EMA和FDA建议

In our News dated 18 February we reported on a question & answer (Q&A) paper which was published by EMA and FDA together at the end of 2014. This document answers questions on detailed requirements in connection with the documents concerning regulatory submissions. It also answers a question on the topic design of experiments (DOE).

在我们2月18日新闻中，我们报道了一份由EMA和FDA在2014年年底联合签发的问答。该文件回答了关于法规申报资料中文件详细程度的问题，还回答了一个关于实验设计主题的问题。

The document answers the question "What level of detail should be considered for design of experiments (DOEs) in a regulatory submission?" as follows:

该文件回答的问题“法规申报文件中实验设计（DOE）要考虑详细到何种程度？”如下：

The level of detail should be commensurate with the significance of the outcome of the DOE to the selection of the product design, commercial manufacturing process and control strategy. According to the document a DOE to define operating ranges for an important unit operation would normally be considered of high significance. The information provided to the authority in such cases could include:

详细程度应与产品设计、商业生产工艺和控制策略选择DOE的结果的重要性相等同。例如，用于界定一个重要操作单元的操作范围的DOE一般会被认为是较为重要的。这种情况下，可以包括以下内容：

• Type of experimental design and parameter ranges studied. As a supplement it is pointed out that justification for choice of design could be useful.
• 实施设计类型和所研究的参数范围。
• Tables summarizing inputs and outputs, including batch size.
• 投料量和收量总结表，包括批量
• Summary of parameters that were kept constant during the DOE.
• 实验设计中保持不变的参数总结
• Delineation of factors as scale dependent or independent, with justification (for example experimental results, scientific rationale, prior knowledge).
• 因素划分为相互依赖的和独立的，包括论证（例如，实验结果、科学理论、之前的知识）
• Description of main effects and interactions on response variables, including statistical significance of parameters (p-value).
• 主要影响和相互反应响应变量描述，包括参数的统计学显著性（p值）
• Discussion of regression model validation parameters (such as output from ANOVA regression analysis, residual plots, etc.) if applicable.
• 适用时，回归模式验证参数（例如，因子表、ANOVA回归分析结果、残差图、拟合性（R2）、预测符合性、预测返回值与置信区间表格）的讨论
  

Please also see the "Questions and answers on level of detail in the regulatory submissions".

详细内容参见“法规申报文件详细程度问答”。

来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201512610381387/

谢谢分享，已学习

如果资料要写成这样的话，还有很长的路要走啊