New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment (2 of 2)
ฝัง
- เผยแพร่เมื่อ 6 ธ.ค. 2020
- FDA and multiple regulatory and industry members from the International Council for Harmonisation (ICH) E14/S7B Implementation Working Group present on the Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential. The working group developed new Questions & Answers (Q&As) to ICH E14 and S7B, which were released by ICH as a Draft Guideline for public consultation on August 27, 2020.
Presenters cover the background, motivation for, and overview of the new Q&As for ICH E14/S7B, followed by presentations on each of the main Q&A topics. Example cases will be presented that highlight the potential impact of applying the principles in the new Q&As on drug development and regulatory evaluation.
The new Q&As describe how nonclinical assays can be used as a part of an integrated risk assessment prior to first-in-human studies as they are used today, and in later stages of clinical development as a part of a combined nonclinical-clinical integrated risk assessment. If implemented, they can lead to a reduction in the number of ‘Thorough QT’ clinical studies and improved decision making at the time of a marketing application.
Learn more at: www.fda.gov/drugs/news-events...
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Upcoming Training - www.fda.gov/cdersbia
SBIA Listserv - public.govdelivery.com/accoun...
SBIA 2020 Playlist - th-cam.com/users/playlist?list...
SBIA LinkedIn - / cder-small-business-an...
SBIA Training Resources - www.fda.gov/cderbsbialearn
Twitter - / fda_drug_info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367