Keywords: Concentration-QTc (C-QTc),ICH E-14,Assay Sensitivity,QT Interdisciplinary Review Team (QT-IRT),Regulatory,TQT
The objective of this poster is to define good practices on how to plan, conduct, and report C-QTc modeling as the primary analysis for regulatory submissions to the Agency and to report updates from FDA QT-Interdisciplinary Review Team (QT-IRT).
The ICH E14 Q&A revision 3 (R3) in December 2015 provided a pathway for concentration-QTc modeling as an alternative to the traditional intersection-union test for the primary analysis for QTc effects. Since then QT-IRT has observed a new trend of substantial number of submissions with C-QTc modeling as the primary analysis for assessing QTc prolongation risk of new drug products in regulatory submissions.
Statistics on these new trends in regulatory submissions to FDA will be shared. Requirements and evaluation of adequacy of information needed to avail this regulatory pathway provided by ICH E14 Q&A (R3) will be discussed. This poster will present recommendations on good practices on how to plan, conduct, and report C-QTc modeling as the primary analysis for regulatory submissions from regulatory experience and the Scientific White Paper on concentration-QTc modeling*.
*Reference: Garnett C. et al. J Pharmacokinet Pharmacodyn ; 2017; doi 10.1007/s10928-017-9558-5