2005年1月6日 · This document provides principles for assessing the comparability of biotechnological or biological products before and after changes are made in the manufacturing process for the drug substance or drug product.

ICH HARMONISED TRIPARTITE GUIDELINE COMPARABILITY OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS Q5E Current Step 4 version dated 18 November 2004 This Guideline has been developed by the appropriate ICH Expert Working Group and has been …

2023年11月1日 · Q5A - Q5E Quality of Biotechnological Products/生物技术产品质量 ... 国家药品监督管理局药品审评中心ICH办公室工作专栏相关信息 ...

2023年11月1日 · Q5A - Q5E Quality of Biotechnological Products/生物技术产品质量: Q5A(R2)：Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin: Q5A（R2）：来源于人或动物细胞系生物技术产品的病毒安全性评价: 阶 …

Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process This guidance represents the Food and Drug Administration's (FDA's) current thinking on...

Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process dated 5 February 2002 Endorsed by the Steering Committee on 7 February 2002 Type of Harmonisation Action Proposed A new tripartite, harmonised guideline is proposed in the Quality topic area on the

The objective of this document is to provide principles for assessing the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product.

本文件以之前发布的ich指导原则为基础，增加了以下的指导内容： 比较生产工艺变更前后的产品。 评估由于生产工艺变更对特定的产品质量带来的可检测到的差异，这些差异与产品的安全性和有效性相关。

2017年9月27日 · This chapter provides examples and case studies to illustrate the practical application of the ICH Q5E guideline to real-life biological product manufacture.

2021年4月26日 · Comparability Exercise (ICH Q5E): Principles and key to success ICH Q5E Experts Working Group