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van Dijkman SC on Muck Rack

van Dijkman SC

As seen in: British Pharmacological Society
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Comment on ‘An open-label, single-arm, dose-escalating concentration–QT study to investigate the cardiac effects and safety of paroxetine in healthy adults’

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By Sant Tukaram Nagar, Pimpri Pune India, van Dijkman SC
| British Pharmacological Society
To the Editor, van Dijkman and colleagues report an open-label, single-arm, dose-escalating concentration–QT study in 38 healthy adults receiving paroxetine 20- to 60-mg QD, concluding that paroxetine does not prolong QTc to any clinically meaningful extent at therapeutic doses.1 The pharmacokinetic–pharmacodynamic modelling is technically competent, and the design follows ICH E14/S7B (2022) provisions for omitting placebo when prior suspicion of QT prolongation is low.
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