Multi-site validation of in vivo QT ICH E14/S7B Q&A guidance in canines and nonhuman primates

SPS 2023 -- The new ICH E14/S7B Q&A guidelines introduce the concept of "double negative" (negative hERG and negative in vivo QTc) nonclinical data that can be used along with negative Phase I clinical QTc data to substitute for a clinical thorough QT study in specific cases (Q&As 5.1 and 6.1). The nonclinical data are to be generated using "best practice" designs in order to ensure data quality and consistency across the industry. For the in vivo QT assay, best practice recommendations require characterization of individual study sensitivity, verification of independence QTc from heart rate and demonstration of test facility sensitivity and pharmacological translation to human using a positive control.

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