New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment (1 of 2) скачать в хорошем качестве

New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment (1 of 2)

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: https://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 - https://www.fda.gov/cdersbia    SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2020 Playlist - https://www.youtube.com/playlist?list... SBIA LinkedIn -   / cder-small-business-and-industry-assistance     SBIA Training Resources - https://www.fda.gov/cderbsbialearn   Twitter -   / fda_drug_info     Email - CDERSBIA@fda.hhs.gov   Phone - (301) 796-6707 I (866) 405-5367