FDA E14 Clinical Evaluation of QTQTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (2)
标准简介
E14 Clinical Evaluation of QTQTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (2)[附网盘链接]由FDA于之前发布，适用于美国。标准截图
![E14 Clinical Evaluation of QTQTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (2)[附网盘链接]](/img/202109141037320no9r.jpg)
标准文档说明
标准文档类型为E14 Clinical Evaluation of QTQTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (2)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs — Questions and Answers (R3) 1
Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. INTRODUCTION Since the ICH E14 guidance was finalized in 2005, experiences implementing the guidance in the ICH regions have given rise to requests for clarification. This question and answer (Q&A) document is intended to facilitate implementing the E14 guidance by clarifying key issues. This guidance is a revision of the ICH guidance titled E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs – Questions and Answers (November 2008). This Q&A document has been revised as follows: • In April 2012, added questions on Sex Differences, Incorporating New Technologies, Late Stage Monitoring, and Heart Rate Correction • In March 2014, added questions on Concentration-Response Relationships, Combination Products, Large Targeted Proteins and Monoclonal Antibodies, and Special Cases • In December 2015, revised the question on Use of Concentration Response Modeling of QTC Data, to harmonize guidance on how concentration response modeling could be used for regulatory decision-making This revised guidance incorporates the March 2014 and December 2015 changes. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 1
This guidance was developed within the Expert Working Group (Efficacy) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) (formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) and has been subject to consultation by the regulatory parties, in accordance with the ICH process. This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, December 2015. At Step 4 of the process, the final draft is recommended for adoption to the regulatory authorities represented at ICH.
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