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

Autor: Claudia Meyer, Ines Dierick, Glenn Gauderat, Jurgen Langenhorst, Céline Sarr, Emilie Leroux, Marylore Chenel, Sylvain Fouliard, Paul Passier
Rok vydání: 2022
Předmět:
Zdroj: Clinical Pharmacology & Therapeutics. 113:310-320
ISSN: 1532-6535
0009-9236
DOI: 10.1002/cpt.2596
Popis: 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.
Databáze: OpenAIRE
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