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On comparison of SAS codes with GLM and MIXED for the crossover studies with QT interval data

Choi K, Hong T, Lee J

The structural complexity of crossover studies for bioequivalence test confuses analysts and leaves them a hard choice among various programs. Our study reviews PROC GLM and PROC MIXED in SAS...
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The Safety and Pharmacokinetics of Cyanidin-3-Glucoside after 2-Week Administration of Black Bean Seed Coat Extract in Healthy Subjects

Jeon S, Han S, Lee J, Hong T, Yim DS

We analyzed the pharmacokinetics of C3G on data from twelve subjects, after 2-week multiple dosing of black bean (Phaseolus vulgaris, Cheongjakong-3-ho) seed coat extract, using the mixed effect analysis method...
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A Review of Fundamentals of Statistical Concepts in Clinical Trials

Choi K, Lee J, Jeon S, Hong T, Paek J, Han S, Yim DS

  • KMID: 2334531
  • J Korean Soc Clin Pharmacol Ther.
  • 2012 Dec;20(2):109-124.
Statistical analysts engaged in typical clinical trials often have to confront a tight schedule to finish massive statistical analyses specified in a Standard Operation Procedure (SOP). Thus, statisticians or not,...
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Physiologically-based pharmacokinetic predictions of intestinal BCRP-mediated drug interactions of rosuvastatin in Koreans

Bae SH, Park WS, Han S, Park GJ, Lee J, Hong T, Jeon S, Yim DS

It was recently reported that the C(max) and AUC of rosuvastatin increases when it is coadministered with telmisartan and cyclosporine. Rosuvastatin is known to be a substrate of OATP1B1, OATP1B3,...
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Decreased potency of fimasartan in liver cirrhosis was quantified using mixed-effects analysis

Kim CO, Jeon S, Han S, Hong T, Park MS, Yoon YR, Yim DS

Fimasartan is a nonpeptide angiotensin II receptor blocker. In a previous study that compared the pharmacokinetics (PK) of fimasartan between patients with hepatic impairment (cirrhosis) and healthy subjects, the exposure...
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Single institute experience of pancreatico-enteric anastomosis failure after pancreaticoduodenectomy

Woo Y, You Y, Han J, Choi H, Kim Y, Kwak B, Hong T, Kim D

PURPOSE: We have summarized the experience of our institution related to what treatment has been performed in patients with pancreatic fistula and their outcome. METHODS: Seventy-eight pancreatico-enteric anastomosis failure (PEAF) patients...
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Bone Marrow-Derived Mesenchymal Stem Cells Isolated from Patients with Cirrhosis and Healthy Volunteers Show Comparable Characteristics

Lim YL, Eom YW, Park SJ, Hong T, Kang SH, Baik SK, Park KS, Kim MY

Background and Objectives: Autologous or allogeneic bone marrow-derived mesenchymal stem cells (BMSCs) have been applied in clinical trials to treat liver disease. However, only a few studies are comparing the...
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High Resolution 3D Magnetic Resonance Fingerprinting with Hybrid Radial-Interleaved EPI Acquisition for Knee Cartilage T1 , T2 Mapping

Han D, Hong T, Lee Y, Kim DH

Purpose: To develop a 3D magnetic resonance fingerprinting (MRF) method for application in high resolution knee cartilage PD, T1 , T2 mapping. Materials and Methods: A novel 3D acquisition trajectory with...
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Evaluation of pharmacokinetic interactions between amoxicillin, clarithromycin, and the potassium-competitive acid blocker YH4808 in healthy subjects

Lee WY, Oh E, Cui M, Kim CO, Lim Y, Kim H, Park H, Yoon S, Park MS, Hong T

YH4808 is a novel potassium-competitive acid blocker that was developed as a therapeutic agent for gastric acid-related diseases; it may replace proton pump inhibitors, which are widely used in combination...
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Pharmacokinetic drug interaction between atorvastatin and ezetimibe in healthy Korean volunteers

Park J, Kim CO, Jin BH, Yang S, Park MS, Hong T

Atorvastatin and ezetimibe are frequently co-administered to treat patients with dyslipidemia for the purpose of low-density lipoprotein cholesterol control. However, pharmacokinetic (PK) drug interaction between atorvastatin and ezetimibe has not...
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Comparison of the Population Pharmacokinetics and Safety Between Please Orally Soluble Film and VIAGRA(R) in Healthy Male Volunteers

Hong T, Lee J, Jeon S, Paek J, Kim HI, Kwak SS, Park SJ, Han S, Yim DS

  • KMID: 2334542
  • J Korean Soc Clin Pharmacol Ther.
  • 2013 Jun;21(1):26-33.
BACKGROUND: The objective of this study was to compare the pharmacokinetics and safety between newly developed sildenafil (Please Orally Soluble Film) and sildenafil citrate (VIAGRA(R)) after single oral administration in...
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Effects of high occupational physical activity, aging, and exercise on heart rate variability among male workers

Kang D, Kim Y, Kim J, Hwang Y, Cho B, Hong T, Sung B, Lee Y

OBJECTIVES: Effects of aging and leisure time physical activity (LPA) might influence the effect of occupational physical activity (OPA) on risk for cardiovascular disease (CVD). This study was conducted to...
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Pharmacokinetics and Safety of Levodropropizine Controlled Release Tablet after Repeated Dosing in Healthy Male Volunteers

Jeon S, Lee J, Hong T, Paek J, Han S, Yim DS

BACKGROUND: Levodropropizine is non-opioid agent whose peripheral antitussive action may result from its modulation of sensory neuropeptide levels. Currently, levodropropizine 60 mg is taken three-times daily. A controlled release formulation...
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Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial

Kang K, Han S, Hong T, Jeon S, Paek J, Kang JH, Yim DS

PURPOSE: A phase I clinical trial was conducted to evaluate the immunogenicity and safety of newly developed egg-cultivated trivalent inactivated split influenza vaccine (TIV) in Korea. MATERIALS AND METHODS: The TIV...
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