Testing the nonclinical Comprehensive In Vitro Proarrhythmia Assay (CiPA) paradigm with an established anti‐seizure medication: Levetiracetam case study

Testing the nonclinical Comprehensive In Vitro Proarrhythmia Assay (CiPA) paradigm with an established anti‐seizure medication: Levetiracetam case study

Abstract Levetiracetam (LEV), a well‐established anti‐seizure medication (ASM), was launched before the original ICH S7B nonclinical guidance assessing QT prolongation potential and the introduction of the Comprehensive In Vitro Proarrhythmia Assay (CiPA) paradigm. No information was available on it...

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Bibliographic Details
Main Authors: Annie Delaunois, François‐Xavier Mathy, Miranda Cornet, Vitalina Gryshkova, Chloé Korlowski, François Bonfitto, Juliane Koch, Anne‐Françoise Schlit, Simon Hebeisen, Elisa Passini, Blanca Rodriguez, Jean‐Pierre Valentin
Format: Article
Language:English
Published: Wiley 2023-02-01
Series:Pharmacology Research & Perspectives
Subjects:
cardiac safety
CiPA
ICH S7B
levetiracetam
nonclinical
QT prolongation
Online Access:https://doi.org/10.1002/prp2.1059

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