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Incorporating exposure‐response modeling into the assessment of QTc interval: A potential alternative to the thorough QT study
Author(s) -
Bloomfield DM
Publication year - 2015
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.92
Subject(s) - qt interval , medicine , drug , clinical pharmacology , pharmacology , intensive care medicine
ICH E14 mandates that a thorough QTc study (TQT) is conducted as part of the clinical drug development program to provide an accurate and precise estimate of a drug's effect on the QTc. In the April issue of CPT , Darpo et al . report the results of a study which validated an alternative approach to evaluating the effect of a drug on QTc using exposure‐response modeling in phase I which has the potential to make the TQT study obsolete.