ICH HARMONISED TRIPARTITE GUIDELINE CHOICE OF CONTROL GROUP AND RELATED ISSUES IN CLINICAL TRIALS E10 Current Step 4 version dated 20 July 2000 This Guideline …

The ICH E11A Guideline reached Step 4 of the ICH process on 21 August 2024. The E11A Guideline provides recommendations and promotes international harmonisation of paediatric …

2001年1月1日 · This document describes the general principles involved in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment and to discuss …

This guidance is intended to assist applicants in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment. The guidance also discusses related trial …

2024年12月11日 · ICH E10: Choice of Control Group and Related Issues in Clinical Trials (PDF - 93KB)

E10 Choice of Control Group in Clinical Trials/试验中对照组的选择; E11 Clinical Trials in Pediatric Population/儿童人群临床研究; E12 Clinical Evaluation by Therapeutic Category/根据治疗类 …

This document addresses the choice of control groups in clinical trials considering the ethical and inferential properties and limitations of different kinds of control groups. It points out the assay …

2001年5月14日 · The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "E10 Choice of Control Group and Related Issues in Clinical Trials." The …

The International Conference on Harmonisation (ICH) has developed a guideline entitled “Choice of Control Group in Clinical Trials” (ICH –E10), which was approved in July 2000 for …

10 Years with ICH E10: Choice of Control Groups. 10 Years with ICH E10: Choice of Control Groups Pharm Stat. 2011 Sep-Oct;10(5):407-9. doi: 10.1002/pst.500. Epub 2011 Sep 16. …