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Post-Marketing Surveillance for the Safety and Effectiveness of Adefovir in Patients with Chronic Hepatitis B

Shin KY, Choi HM, Oh SY, Kim JH, Lee YS, Kweon YO

  • KMID: 2334501
  • J Korean Soc Clin Pharmacol Ther.
  • 2011 Dec;19(2):180-191.
BACKGROUND: To investigate the safety and effectiveness of adefovir in Korean patients with chronic hepatitis B, an observational study was carried out. METHODS: A total of 4,393 patients with chronic hepatitis...
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Analysis of Plasma Long-Chain Fatty Acids in Hypertensive Patients

Kim JS, Kwon GY, Kim SK

  • KMID: 2334500
  • J Korean Soc Clin Pharmacol Ther.
  • 2011 Dec;19(2):166-179.
BACKGROUND: Numerous studies have suggested that polyunsaturated fatty acids (PUFAs)-supplemented diets may decrease cardiovascular morbidity and mortality. Especially, omega-3 PUFAs may exert beneficial effects to the treatment and prevention of...
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Institutional Review Board (IRB) Mutual Recognition Program and Its Feasibility in Korea

Cheong HR, Yim HW, Choe B, Kim YI

  • KMID: 2334499
  • J Korean Soc Clin Pharmacol Ther.
  • 2011 Dec;19(2):152-165.
BACKGROUND: The use of Cooperative Institutional Review Board (Co-IRB) has become subject to continuous discussion. As a result, leading mainly by the Korea Association of Institutional Review Boards (KAIRB), "IRB...
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Pharmacokinetics and Tolerability Evaluation of Human Coagulation Recombinant Factor VIII (GreenGene(TM)) in Hemophilia A Patients

Han H, Shin KH, Paik SH, Chung JY, Lim KS, Cho JY, Yoon SH, Shin SG, Jang IJ, Yu KS

  • KMID: 2334498
  • J Korean Soc Clin Pharmacol Ther.
  • 2011 Dec;19(2):144-151.
BACKGROUND: GreenGene(TM) (Green Cross Corp.) is a recombinant clotting factor VIII which is used for hemophilia A. This study aimed to investigate the pharmacokinetics and safety profiles of 25 IU/kg...
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The Study of Education and Qualification for the Maintenance of Clinical Research Associate (CRA) Professionalism

Kim KH, Kim KS, Choe B, Kim YI

  • KMID: 2334497
  • J Korean Soc Clin Pharmacol Ther.
  • 2011 Dec;19(2):130-143.
BACKGROUND: The aim of the current study is to investigate perspectives on the quality and validity of the current clinical research associate (CRA) education program. The trainee program of other...
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Current Tasks and Appropriate Tasks of Clinical Research Coordinators in Korea

Jeong IS

  • KMID: 2334496
  • J Korean Soc Clin Pharmacol Ther.
  • 2011 Dec;19(2):117-129.
BACKGROUND: This study was aimed to investigate current tasks done by clinical research coordinators (CRCs) and appropriate tasks of CRCs perceived by investigators, and to classify tasks for CRCs into...
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Application of Method to Measure Calcineurin Activity in Healthy Human Volunteers after Cyclosporine Administration

Lim MS, Seong SJ, Park JH, Seo JJ, Lee J, Lee HW, Yoon YR

  • KMID: 2334495
  • J Korean Soc Clin Pharmacol Ther.
  • 2011 Dec;19(2):109-116.
BACKGROUND: Calcineurin-inhibitors have wide inter-individual variation in drug response. Although therapeutic drug monitoring has been conducted to optimize personalized regimen, toxicity or rejection may occur. In this study, pharmacologic effect...
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A Study on Management and Report of Adverse Event in Clinical Trials

Lee S, Kim YI, Yim H, Lee G, Choe B

  • KMID: 2334494
  • J Korean Soc Clin Pharmacol Ther.
  • 2011 Dec;19(2):98-108.
BACKGROUND: This research is to identify the difficulties occuring in the course of managing the adverse events and the adverse event related standard operating procedure in the regulation of each...
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Pharmacokinetics and Tolerability Evaluation of Fudosteine after Oral Administration in Healthy Korean Volunteers

Ahn LY, Shin KH, Lim KS, Chung JY, Lee SI, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS

  • KMID: 2334493
  • J Korean Soc Clin Pharmacol Ther.
  • 2011 Dec;19(2):91-97.
BACKGROUND: Fudosteine, (-)-(R)-2-amino-3-(3-hydroxypropylthio)propionic acid, is a cysteine derivative that was approved in Japan, as a new mucoactive agent. The aim of this study was to evaluate the tolerability and pharmacokinetics...
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Evaluation of Pharmacokinetics and Tolerability of Eplerenone after Multiple Oral Doses of 100 mg in Healthy Korean Volunteers

Yoon S, Lee S, Oh DS, Lim KS, Shin SG, Jang IJ, Yu KS

  • KMID: 2334492
  • J Korean Soc Clin Pharmacol Ther.
  • 2011 Dec;19(2):84-90.
BACKGROUND: Eplerenone is a selective mineralocorticoid receptor antagonist which effectively blocks mineralocorticoid receptors in various tissues throughout the body. The addition of eplerenone to optimal medical therapy reduces morbidity and...
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Influence of Simvastatin on Pharmacokinetics/Pharmacodynamics of Aspirin after Oral Co-administration in Healthy Volunteers

Gu N, Kim BH, Chung YJ, Lim KS, Seo HB, Yim DS, Shin SG, Jang IJ, Yu KS

  • KMID: 2334491
  • J Korean Soc Clin Pharmacol Ther.
  • 2011 Dec;19(2):73-83.
BACKGROUND: Both aspirin and simvastatin are prescribed as treatments or prevention of cardiovascular diseases. The aim of this study was to investigate the influence of simvastatin on pharmacokinetics and pharmacodynamics...
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