How to Successfully Generate an Alternative Approach to a Thorough QT Study: GLPG1972 as an Example

During development of a drug, the requirement of evaluating the proarrhythmic risk and delayed repolarization needs to be fulfilled. Would it be possible to create an alternative to a thorough QT (TQT) study or is there a need to perform a dedicated TQT study? How is an alternative approach generate...

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Autores principales: Meyer, Claudia, Dierick, Ines, Gauderat, Glenn, Langenhorst, Jurgen, Sarr, Céline, Leroux, Emilie, Chenel, Marylore, Fouliard, Sylvain, Passier, Paul
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Tutorials
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10083980/
https://www.ncbi.nlm.nih.gov/pubmed/35355254
http://dx.doi.org/10.1002/cpt.2596
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author Meyer, Claudia
Dierick, Ines
Gauderat, Glenn
Langenhorst, Jurgen
Sarr, Céline
Leroux, Emilie
Chenel, Marylore
Fouliard, Sylvain
Passier, Paul
author_facet Meyer, Claudia
Dierick, Ines
Gauderat, Glenn
Langenhorst, Jurgen
Sarr, Céline
Leroux, Emilie
Chenel, Marylore
Fouliard, Sylvain
Passier, Paul
author_sort Meyer, Claudia
collection PubMed
description During development of a drug, the requirement of evaluating the proarrhythmic risk and delayed repolarization needs to be fulfilled. Would it be possible to create an alternative to a thorough QT (TQT) study or is there a need to perform a dedicated TQT study? How is an alternative approach generated, what information is available, and which instructions are considered missing today to generate such an approach? This tutorial describes the considerations and path followed to create an early and feasible alternative to a TQT study using experience‐based insights from a successful application to the US Food and Drug Administration for GLPG1972, an ADAMTS‐5 inhibitor, and discusses the approach used in light of the current guidelines and literature.
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spelling pubmed-100839802023-04-11 How to Successfully Generate an Alternative Approach to a Thorough QT Study: GLPG1972 as an Example Meyer, Claudia Dierick, Ines Gauderat, Glenn Langenhorst, Jurgen Sarr, Céline Leroux, Emilie Chenel, Marylore Fouliard, Sylvain Passier, Paul Clin Pharmacol Ther Tutorials During development of a drug, the requirement of evaluating the proarrhythmic risk and delayed repolarization needs to be fulfilled. Would it be possible to create an alternative to a thorough QT (TQT) study or is there a need to perform a dedicated TQT study? How is an alternative approach generated, what information is available, and which instructions are considered missing today to generate such an approach? This tutorial describes the considerations and path followed to create an early and feasible alternative to a TQT study using experience‐based insights from a successful application to the US Food and Drug Administration for GLPG1972, an ADAMTS‐5 inhibitor, and discusses the approach used in light of the current guidelines and literature. John Wiley and Sons Inc. 2022-04-27 /pmc/articles/PMC10083980/ /pubmed/35355254 http://dx.doi.org/10.1002/cpt.2596 Text en © 2022 Galapagos NV. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Tutorials
Meyer, Claudia
Dierick, Ines
Gauderat, Glenn
Langenhorst, Jurgen
Sarr, Céline
Leroux, Emilie
Chenel, Marylore
Fouliard, Sylvain
Passier, Paul
How to Successfully Generate an Alternative Approach to a Thorough QT Study: GLPG1972 as an Example
title How to Successfully Generate an Alternative Approach to a Thorough QT Study: GLPG1972 as an Example
title_full How to Successfully Generate an Alternative Approach to a Thorough QT Study: GLPG1972 as an Example
title_fullStr How to Successfully Generate an Alternative Approach to a Thorough QT Study: GLPG1972 as an Example
title_full_unstemmed How to Successfully Generate an Alternative Approach to a Thorough QT Study: GLPG1972 as an Example
title_short How to Successfully Generate an Alternative Approach to a Thorough QT Study: GLPG1972 as an Example
title_sort how to successfully generate an alternative approach to a thorough qt study: glpg1972 as an example
topic Tutorials
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10083980/
https://www.ncbi.nlm.nih.gov/pubmed/35355254
http://dx.doi.org/10.1002/cpt.2596
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