title: Magnetocardiography for pharmacology safety studies requiring high patient throughput and reliability.
abstract: Recent guideline drafts of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) underline the necessity to test nonantiarrhythmic drugs for their potential to prolong the QT or the corrected QT (QTc) interval. The implementation of these guidelines requires a large amount of ECG measurements on animals and humans in preclinical and clinical phases of the drug development process. We propose the use of magnetocardiography (MCG) as a complementary method with particular advantages in high-throughput studies, where signal quality and reliability are key factors. Our proposal is based on a review of recent MCG studies investigating the repolarization phase and results of methodological work assessing QT interval parameters from the MCG. The applicability of MCG for pre-clinical in-vivo studies is demonstrated by the ease of measurement in unrestrained non-anesthetized rabbits, guinea pigs, and hamsters..
authors.affiliation: Department of Biosignals, Physikalisch-Technische Bundesanstalt, Berlin, Germany. uwe.steinhoff@ptb.de
authors.forename: Uwe
authors.initials: U
authors.lastname: Steinhoff
authors.forename: Silvia
authors.initials: S
authors.lastname: Knappe-Grueneberg
authors.forename: Allard
authors.initials: A
authors.lastname: Schnabel
authors.forename: Lutz
authors.initials: L
authors.lastname: Trahms
authors.forename: Fiona
authors.initials: F
authors.lastname: Smith
authors.forename: Philip
authors.initials: P
authors.lastname: Langley
authors.forename: Alan
authors.initials: A
authors.lastname: Murray
authors.forename: Hans
authors.initials: H
authors.lastname: Koch
mesh_terms: D000818:Animals; D006224:Cricetinae; D004341:Drug Evaluation; D004353:Drug Evaluation, Preclinical; D004562:Electrocardiography / Q000187:drug effects; D006168:Guinea Pigs; D006334:Heart Function Tests; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008280:Magnetics; D009200:Myocardial Contraction / Q000187:drug effects; D010600:Pharmacology; D011817:Rabbits; D015203:Reproducibility of Results; D012449:Safety