title: Incorporating exposure-response modeling into the assessment of QTc interval: A potential alternative to the thorough QT study.
abstract: 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.
authors: Cardiovascular Global Clinical Development, Merck and Co., Inc. Rapporteur, ICH E14 Working Group.
authors: D M
authors: DM
authors: Bloomfield
mesh_terms: D002317:Cardiovascular Agents / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D004562:Electrocardiography / Q000187:drug effects*; D005260:Female; D006801:Humans; D008133:Long QT Syndrome / Q000188:drug therapy*; D008297:Male
chemical_list: D002317:Cardiovascular Agents