Application of Trial Simulation in the Design of a Prospective Study for Concentration-QTc Analysis...
Application of Trial Simulation in the Design of a Prospective Study for Concentration-QTc Analysis in Support of a Thorough QT Study Waiver
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Publisher
Cham: Springer International Publishing
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Language
English
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Cham: Springer International Publishing
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The concentration-QTc (C-QTc) analysis is often applied in the first-in-human (FIH) study to demonstrate the absence of a QTc effect in support of a TQT waiver. However, a C-QTc analysis without properly designed sensitivity could fail to conclude the absence of a QTc effect at high concentrations, even though the compound is QTc negative. This is...
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Full title
Application of Trial Simulation in the Design of a Prospective Study for Concentration-QTc Analysis in Support of a Thorough QT Study Waiver
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TN_cdi_proquest_miscellaneous_2430093189
Permalink
https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_proquest_miscellaneous_2430093189
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ISSN
1550-7416
E-ISSN
1550-7416
DOI
10.1208/s12248-020-00488-3
