Q&A Step 4 (Feb 2022)
ICH E14/S7B Q&As — Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation
ABSTRACT — EDITORS' SUMMARY
Formal Q&A companion to E14 (clinical) and S7B (nonclinical) covering QT/QTc study design, methodology, gender, positive controls, and integration with hERG assay data. Peripheral to GCP-inspection scope but the only formal E14 Q&A published by ICH.
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PDF · CANONICAL LINK https://database.ich.org/sites/default/files/E14-S7B_QAs_Step4_2022_0221.pdf ↗ RELATED · SAME AUTHORITY