Teneligliptin and “Thorough QTc study”: thorough enough?

Samit GhosalDepartment of Endocrinology, Nightingale Hospital, Kolkata, IndiaI read with interest the “Thorough QTc study” with teneligliptin by Erande et al.1 It came as a surprise to me that the basic structure required to conduct such a trial as per the ICH E...

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Autor principal: Ghosal S
Formato: article
Lenguaje:EN
Publicado: Dove Medical Press 2019
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Acceso en línea:https://doaj.org/article/e0bb67106fff4eed93e4707707127c4c
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Sumario:Samit GhosalDepartment of Endocrinology, Nightingale Hospital, Kolkata, IndiaI read with interest the “Thorough QTc study” with teneligliptin by Erande et al.1 It came as a surprise to me that the basic structure required to conduct such a trial as per the ICH E14 recommendations for the industry was not followed.2 The recommended design to conduct such a trial was not universally followed (Table1).View the original paper by Erande and colleagues