- Acid-Suppressive Therapy and Risk for C. difficile Infection: A Systematic Review and Meta-Analysis
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Oh D, Kim KR, Cheon S, Chung JE
- KMID: 2564483
- Pharmacoepidemiol Risk Manage.
- 2024 Sep;16(2):192-201.
- doi: 10.56142/perm.24.0018
Objective: Acid-suppressive therapy is commonly used for stress ulcers; however, concerns have been raised regarding its potential to increase the risk of Clostridioides difficile infection (CDI). This study aimed to compare... -
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- Translation of HARmonized Protocol Template to Enhance Reproducibility of Hypothesis Evaluating Real-World Evidence Studies on Treatment Effects: A Good Practices Report of a Joint ISPE/ ISPOR Task Force
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Park S, Kim HJ, Cho H, Kim JA, Lee HE, Won H, Kim YJ, Shin JY, Lee J, Choi NK
- KMID: 2564475
- Pharmacoepidemiol Risk Manage.
- 2024 Sep;16(2):100-112.
- doi: 10.56142/perm.24.0010
Reproducibility and transparency are fundamental scientific principles that enhance research efficiency, facilitate corrections, and strengthen the reliability of published literature. The clearer each stage of the research process is, the... -
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- Incidence and Risk Factors of Hyperammonemia Secondary to L-asparaginase in Children with Leukemia or Lymphoma
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Lee SY, Song SJ, Yoon J, Kim HJ, Ahn KM, Suh DI, Kang HR, Hong KT
- KMID: 2564479
- Pharmacoepidemiol Risk Manage.
- 2024 Sep;16(2):146-155.
- doi: 10.56142/perm.24.0014
Objective: Ammonia generated during breakdown of L-asparaginase is elevated due to excessive production or hindrance of ammonia conversion to urea. While children are in condition of growth and have faster... -
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- Risk of Osteoporosis Associated with HMG-CoA Reductase Inhibitors in Patients with Dyslipidemia: A Retrospective Cohort Study in Korea
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Yang H, Shim D, Choi E, Yoo M, Kim B
- KMID: 2564478
- Pharmacoepidemiol Risk Manage.
- 2024 Sep;16(2):135-145.
- doi: 10.56142/perm.24.0012
Objective: 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (i.e., statins) are widely used to treat dyslipidemia. Several studies indicate that statin users have greater bone mineral density and a lower risk of... -
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- Monitoring Ethambutol-Induced Optic Neuropathy in Tuberculosis Treatment: A Systematic Review of Guidelines and Recommendations
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An S, Kim J
- KMID: 2564477
- Pharmacoepidemiol Risk Manage.
- 2024 Sep;16(2):124-134.
- doi: 10.56142/perm.24.0015
Tuberculosis remains a significant public health issue globally despite being preventable and treatable. This study reviews domestic and international tuberculosis treatment guidelines, focusing on recommendations for preventing ethambutol-induced optic neuropathy,... -
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- Descriptive Analysis of Medication Errors and Contributing Factors in Clinical Trials at a Single Institution
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Kim SM, Jung HS, Jang HW, Baek JH, Lee JY, Ah YM
- KMID: 2564481
- Pharmacoepidemiol Risk Manage.
- 2024 Sep;16(2):172-181.
- doi: 10.56142/perm.24.0019
Objective: This study aimed to classify medication errors during clinical trials by stage of medication use, identify error types, and analyze associated factors at a single institution. Methods: Data were... -
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- Drug Induced Hyponatremia in the Elderly
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Song YR
- KMID: 2564474
- Pharmacoepidemiol Risk Manage.
- 2024 Sep;16(2):91-99.
- doi: 10.56142/perm.24.0011
Hyponatremia is the most common electrolyte imbalance and usually induced by renal water retention due to the presence of factors contributing to increased antidiuretic hormone, low glomerular filtration rate and... -
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- Effectiveness and Safety of TacrolimusMycophenolate Combination Therapy vs. Tacrolimus Monotherapy in Pediatric Liver Transplantation
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Cheon SY, Jeong Jh, Choi JY, Cho EJ, Baek JH, Yi NJ, Lee JY
- KMID: 2564482
- Pharmacoepidemiol Risk Manage.
- 2024 Sep;16(2):182-191.
- doi: 10.56142/perm.24.0017
Objective: The clinical outcome of mycophenolate (MPA) combined with tacrolimus in pediatric liver transplantation (LT) are not well understood. This study aimed to evaluate the effectiveness and safety of MPA... -
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- Status of Awareness and Use of RealWorld Data and Real-World Evidence in the Domestic Drug Approval Process: Insights from the Survey Study
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Yuk JY, Park SJ, Ko HY, Sung HG, Jung JA, Shin JY
- KMID: 2564480
- Pharmacoepidemiol Risk Manage.
- 2024 Sep;16(2):156-171.
- doi: 10.56142/perm.24.0016
Objective: Real-World Data (RWD) and Real-World Evidence (RWE) complement the limitations of clinical trials and play a crucial role in drug development and approval processes. This study assesses the awareness... -
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- Utilization of Real-World Data/RealWorld Evidence for Complementary and Alternative to Clinical Trials: Trends in Guideline Development from the United States, Europe, Japan, and South Korea
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Park J, Lee JE, Choe Y, Jung H, Park SJ, Oh Ji, Kim JH, Shin JY
- KMID: 2564476
- Pharmacoepidemiol Risk Manage.
- 2024 Sep;16(2):113-123.
- doi: 10.56142/perm.24.0013
The increasing development of new drugs for rare diseases has posed challenges to the use of randomization in clinical trials. Therefore, the importance of regulatory decision-making utilizing real-world data (RWD)... -
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