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FDA initiatives to support dose optimization in oncology drug development: the less may be the better

Moon H

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A simple time-to-event model with NONMEM featuring right-censoring

Tran QT, Chae Jw, Bae KS, Yun Hy

In healthcare situations, time-to-event (TTE) data are common outcomes. A parametric approach is often employed to handle TTE data because it is possible to easily visualize different scenarios via simulation....
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Lessons from a multicenter clinical trial with an approved wearable electrocardiogram: issues and practical considerations

Huh KY, Jeong SI, Yoo H, Piao M, Ryu H, Kim H, Yoon YR, Seong SJ, Lee S, Kim KH

Although wearable electrocardiograms (ECGs) are being increasingly applied in clinical settings, validation methods have not been standardized. As an exploratory evaluation, we performed a multicenter clinical trial implementing an approved...
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Therapeutic drug monitoring on the use of transplacental digoxin in fetal tachyarrhythmia: a case report

Jeong SI, Won H, Song I, Oh J

Fetal tachycardia (FT) is a rare disorder and is associated with significant mortality of fetus. Digoxin is one of the antiarrhythmic agents used to treat FT via transplacental therapy. In...
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Comparative pharmacokinetics between two tablets of tramadol 37.5 mg/acetaminophen 325 mg and one tablet of tramadol 75 mg/acetaminophen 650 mg for extended-release fixed-dose combination

Kim HC, Yoon DY, Lee S, Jang IJ, Hong JH, Kim J

An extended-release (ER) fixed-dose combination (FDC) of tramadol 37.5 mg/acetaminophen 325 mg was developed due to the demand for varying dosages. This study aimed to evaluate the pharmacokinetics (PKs) for...
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Bioanalytical methods for the detection of duloxetine and thioctic acid in plasma using ultra performance liquid chromatography with tandem mass spectrometry (UPLC-MS/MS)

Wei Z, Jeong HC, Kang YJ, Jang J, Kim MH, Shin KH

Duloxetine and thioctic acid (TA) are standard drugs for treating diabetic neuropathy, a primary complication associated with diabetes. In this study, ultra performance liquid chromatography coupled with tandem mass spectrometry...
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