ICH指导原则实施公告情况汇总. 关于我们. ICH指导原则 . 指导原则概况. 质量(Q) 安全性(S) 有效性(E) E1 Clinical Safety for Drugs used in Long-Term Treatment/长期使用的药物的临床安全性. …

""" Define the promptprompt = """You are an expert human annotator working for the search engine Bing.com. ContextEach webpage that matches a Bing search query has three pieces of information displayed on the result page: the url, the title and the snippet. The snippet usually ...The webpage provides efficacy guidelines from the National Medical Products Administration's Center for Drug ...

The purpose of this guidance is to facilitate the registration of medicines among ICH regions* (see Glossary) by recommending a framework for evaluating the impact of ethnic factors* upon a medicine’s effect, i.e., its efficacy and safety at a particular dosage* and dose regimen*.

This document recommends a framework for evaluating the impact of ethnic factors upon a medicine's effect, i.e., its efficacy and safety at a particular dosage and dose regimen. Read together with ICH E5 (R1) Ethnic factors in the acceptability of foreign clinical data - …

2024年12月11日 · ICH E5: Ethnic Factors in the Acceptability of Foreign Clinical Data (PDF - 89KB)

The purpose of this guidance is to facilitate the registration of medicines among ICH regions* (see Glossary) by recommending a framework for evaluating the impact of ethnic factors* upon a medicine’s effect, i.e., its efficacy and safety at a particular dosage* and dose regimen*.

Home Regulatory Information Search for FDA Guidance Documents E5 Ethnic Factors in the Acceptability of Foreign Clinical Data

针对临床试验的设计、实施、分析和报告各方面的一系列 ICH 指南，将有助于实现完整临床数据集的概念。 这些指南包括 GCP（E6）、量-效关系评估（E4）、充分的安全性数据（E1 和 E2）、老年用药研究（E7）、研究结果的报告（E3）、一般临床试验的总体考虑（E8 ...

E5(R1) 微小的修订调整 为更好的实施ICH E5 指导原则,ICH工作组撰写了相关问答文件,具体文件可直接在ICH官网下载。 E5 E5问答 已被指导委员会批准

2024年2月19日 · E5_R1__Guideline-Ethnic Factors in the Acceptability of Foreign Clinical Data 本指南主要介绍ICH中跨地区药品注册的种族数据的监管要求，是桥接试验要求的由来（因为人种有差异性，基因不同）。