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Post-marketing Surveillance of the Safety and Effectiveness of Rosiglitazone/Metformin in Korean Patients with Type 2 Diabetes

Lee H, Park SH, Oh SY, Lee YS

  • KMID: 2334539
  • J Korean Soc Clin Pharmacol Ther.
  • 2012 Dec;20(2):195-204.
BACKGROUND: To evaluate the safety and effectiveness of rosiglitazone/metformin in patients with type 2 (non-insulin-dependent) diabetes. METHODS: A total of 982 patients were enrolled by 19 physicians from November 2003 to...
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Results of 2012 KoNECT Certification Program of the Human Resource Project

Seong SJ, Lim MS, Oak S, Lee J, Park SM, Park J, Seo JJ, Lee HW, Shin SG, Park MS, Yoon YR

  • KMID: 2334538
  • J Korean Soc Clin Pharmacol Ther.
  • 2012 Dec;20(2):182-194.
BACKGROUND: In recent years, clinical trials have considerably increased and relevant education programs to clinical trials have been developed and implemented since 2008 in Korea. To enhance the quality as...
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Targeted Plasma Metabolite Profiling of Metformin in Healthy Korean Volunteers

Lihm HS, Cha J, Seo JJ, Park J, Lee J, Lee HW, Bae KS, Kim W, Yoon YR

  • KMID: 2334537
  • J Korean Soc Clin Pharmacol Ther.
  • 2012 Dec;20(2):175-181.
BACKGROUND: Metformin is an effective oral antihyperglycaemic agent for type 2 diabetes mellitus, with a variety of metabolic effects. In addition to controlling blood glucose level, it has been appeared...
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Retrospective Analysis of Adverse Reactions to Iodinated Contrast Media in Korean

Kim HH, Choi JY, Oh MK, Kim EY, Ghim JR, Choi SJ, Shin JG

  • KMID: 2334536
  • J Korean Soc Clin Pharmacol Ther.
  • 2012 Dec;20(2):165-174.
BACKGROUND: This study was performed to evaluate the prevalence and risk factors on the adverse reactions caused by iodinated contrast media (CM) for computed tomography (CT) examination in a university...
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Statistical Analysis System of Spontaneous Adverse Drug Reaction Reports

Kim S, Wang B, Lee J, Kim B, La H, Park YM, Choi I

  • KMID: 2334535
  • J Korean Soc Clin Pharmacol Ther.
  • 2012 Dec;20(2):155-164.
BACKGROUND: Spontaneous adverse drug reaction (ADR) reporting data has been used for safety of post-market drug surveillance. A system has been required that is able to detect signals associated with...
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Bioequivalence and Dose Proportionality of Olmesartan Medoxomil Formulations

Cho SK, Kim CO, Yu SH, Oh ES, Jang SB, Park YS, Cho K, Chung JY

  • KMID: 2334534
  • J Korean Soc Clin Pharmacol Ther.
  • 2012 Dec;20(2):145-154.
BACKGROUND: Olmesartan medoxomil is an angiotensin II receptor blocker commonly used in hypertension. First objective of this study was to evaluate the bioequivalence of two olmesartan formulations, Olmesartan 20 mg...
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Comparison of Pharmacokinetics and Safety of Two Formulations of Letrozole (2.5 mg) in Healthy Male Volunteers

Noh YH, Bae KS, Cho SH, Choe S, Ghim JL, Jung JA, Kim UJ, Jin SJ, Park HJ, Kim JC, Lim HS

  • KMID: 2334533
  • J Korean Soc Clin Pharmacol Ther.
  • 2012 Dec;20(2):135-144.
BACKGROUND: Letrozole is an oral non-steroidal inhibitor of the aromatase enzyme, which has proven to be a useful drug against breast cancer. METHODS: This single-dose, randomized 2 x 2 crossover study...
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Tolerability and Pharmacokinetics Following a Single Dose of Vardenafil in Healthy Korean Volunteers

Kim S, Lee S, Lim KS, Lim HS, Shin SG, Jang IJ, Yu KS

  • KMID: 2334532
  • J Korean Soc Clin Pharmacol Ther.
  • 2012 Dec;20(2):125-134.
BACKGROUND: Vardenafil is a phosphodiesterase type 5 inhibitor, used in erectile dysfunction. This study aimed to evaluate the pharmacokinetics and tolerability of vardenafil following a single oral administration in healthy...
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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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