FDA发布S7B指南终版：人用药品延迟心室复极（QT间期延长）潜在非临床评价
S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
FDA发布S7B指南终版（Docket No. FDA-2004-D-0366），由CBER与CDER发布，描述评估受试物延迟心室复极潜力的非临床检测策略，涵盖非临床检测方法与综合风险评估。指南指出该领域仍在研究中，未来积累更多非临床与临床数据后可能修订。可随时按21 CFR 10.115(g)(5)提交意见，书面意见须标注该Docket编号。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2004-D-0366
- Issued by:
-
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
This guidance describes a nonclinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization. The guidance includes information concerning nonclinical assays and integrated risk assessments. The assessment of the effects of pharmaceuticals on ventricular repolarization and proarrhythmic risk is the subject of active investigation. When additional data (nonclinical and clinical) are accumulated in the future, they will be evaluated and this guidance might be revised.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2004-D-0366.
来源：FDA 官方药品与生物制品信息 · fda.gov