title: The evaluation and management of drug effects on cardiac conduction (PR and QRS intervals) in clinical development.
abstract: Recent advances in electrocardiographic monitoring and waveform analysis have significantly improved the ability to detect drug-induced changes in cardiac repolarization manifested as changes in the QT/corrected QT interval. These advances have also improved the ability to detect drug-induced changes in cardiac conduction. This White Paper summarizes current opinion, reached by consensus among experts at the Cardiac Safety Research Consortium, on the assessment of electrocardiogram-based safety measurements of the PR and QRS intervals, representing atrioventricular and ventricular conduction, respectively, during drug development.
authors.affiliation: Baxter Healthcare Corporation, Deerfield, IL 60015, USA. adel_nada@baxter.com
authors.forename: Adel
authors.initials: A
authors.lastname: Nada
authors.forename: Gary A
authors.initials: GA
authors.lastname: Gintant
authors.forename: Robert
authors.initials: R
authors.lastname: Kleiman
authors.forename: David E
authors.initials: DE
authors.lastname: Gutstein
authors.forename: Christer
authors.initials: C
authors.lastname: Gottfridsson
authors.forename: Eric L
authors.initials: EL
authors.lastname: Michelson
authors.forename: Colette
authors.initials: C
authors.lastname: Strnadova
authors.forename: Matthew
authors.initials: M
authors.lastname: Killeen
authors.forename: Mary Jane
authors.initials: MJ
authors.lastname: Geiger
authors.forename: Mónica L
authors.initials: ML
authors.lastname: Fiszman
authors.forename: Luana Pesco
authors.initials: LP
authors.lastname: Koplowitz
authors.forename: Glenn F
authors.initials: GF
authors.lastname: Carlson
authors.forename: Ignacio
authors.initials: I
authors.lastname: Rodriguez
authors.forename: Philip T
authors.initials: PT
authors.lastname: Sager
mesh_terms: D000889:Anti-Arrhythmia Agents / Q000494:pharmacology; D002318:Cardiovascular Diseases / Q000503:physiopathology*; D002986:Clinical Trials as Topic; D055808:Drug Discovery; D004353:Drug Evaluation, Preclinical; D004562:Electrocardiography; D006329:Heart Conduction System / Q000187:drug effects*; D006801:Humans; D018570:Risk Assessment
chemical_list: D000889:Anti-Arrhythmia Agents