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Simulation of the AUC Changes after Generic Substitution in Patients

Yim DS

To address the debate on the safety of generic substitution quantitatively, the author compared the change in AUC in virtual patients who were simulated for several different scenarios of generic...
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Systematic Review on Clinical Equivalence of Generic and Brand-name Drugs in Statin Therapy

Shim H, Lee IH

BACKGROUND: Generic medications are approved on the basis of bioequivalence with brand medications in healthy volunteers rather than the target population, there remains a substantial uncertainty regarding their clinical effectiveness...
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Establishment and Significance of Bioequivalence Recommendations for Individual Products-Drugs Acting on Circulatory System and Others

Bae SH, Zheng YF, Kwon MJ, Choi EJ, Bae SK

  • KMID: 2334541
  • J Korean Soc Clin Pharmacol Ther.
  • 2013 Jun;21(1):17-25.
Along with the enactment of a law separating the prescribing and dispensing of drugs in Korea in 2000, attempts at reducing medical expenses by generic substitution have been allowed since...
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Comparison of the Effects of a Brand-name Drug and Its Generic Drug on the Quality of Life of Alzheimer's Disease Patients

Sakakibara M, Kido M, Kuribayashi J, Okada H, Igarashi A, Kamei H, Nabeshima

OBJECTIVE: The pharmacological effects of generic (GE) donepezil are the same as Aricept, its brand-name counterpart. However, little is known as to whether these two drugs provide the same quality...
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A multicenter experience with generic mycophenolate mofetil conversion in stable liver transplant recipients

Kim JM, Kwon CH, Yun IJ, Lee KW, Yu HC, Suh KS, Joh JW, Cho BH

PURPOSE: Generic substitution of brand-name medications can lead to significant cost savings and is an accepted medical practice. This study evaluated clinical and safety outcomes among liver transplant recipients whose...
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A post hoc analysis of intra-subject coefficients of variation in pharmacokinetic measures to calculate optimal sample sizes for bioequivalence studies

Chung I, Oh J, Lee S, Jang IJ, Lee Y, Chung JY

Because bioequivalence studies are performed using a crossover design, information on the intra-subject coefficient of variation (intra-CV) for pharmacokinetic measures is needed when determining the sample size. However, calculated intra-CVs...
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The Impact of Generic Clopidogrel Bisulfate on Platelet Inhibition in Patients with Coronary Artery Stents: Results of the ACCEL-GENERIC Study

Jeong YH, Koh JS, Kang MK, Ahn YJ, Kim IS, Park Y, Hwang SJ, Kwak CH, Hwang JY

BACKGROUND/AIMS: In patients with coronary artery stents, the cost of clopidogrel has been cited as a factor in the premature discontinuation of therapy. Thus, the introduction of lower-cost generic clopidogrel...
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A post hoc analysis of intra-subject coefficients of variation in pharmacokinetic measures to calculate optimal sample sizes for bioequivalence studies

Chung I, Oh J, Lee S, Jang IJ, Lee Y, Chung JY

Because bioequivalence studies are performed using a crossover design, information on the intra-subject coefficient of variation (intra-CV) for pharmacokinetic measures is needed when determining the sample size. However, calculated intra-CVs...
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Imidazole Antifungal Drugs Inhibit the Cell Proliferation and Invasion of Human Breast Cancer Cells

Bae SH, Park JH, Choi HG, Kim H, Kim SH

Breast cancer is currently the most prevalent cancer in women, and its incidence increases every year. Azole antifungal drugs were recently found to have antitumor efficacy in several cancer types....
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Stroke Epidemiology and Stroke Care Services in India

Pandian JD, Sudhan P

  • KMID: 2094551
  • J Stroke.
  • 2013 Sep;15(3):128-134.
Developing countries like India are facing a double burden of communicable and non-communicable diseases. Stroke is one of the leading causes of death and disability in India. The estimated adjusted...
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Efficacy and Tolerability of Generic Mirtazapine (Mirtax) for Major Depressive Disorder: Multicenter, Open-label, Uncontrolled, Prospective Study

Song HR, Bahk WM, Woo YS, Jeong JH, Kwon YJ, Seo JS, Kim W, Kim MD, Shin YC, Lee SY, Min KJ

OBJECTIVE: Mirtax is a generic mirtazapine widely used since 2003. We conducted an open-label, uncontrolled 6-week study to evaluate the efficacy and safety of Mirtax for major depressive disorder (MDD). METHODS:...
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Efficacy and Safety of Tamsulosin for Treating Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled, Open-Label Non-Inferiority Study

Lee HS, Kim SW, Oh SJ, Choo MS, Lee KS

  • KMID: 2315509
  • Korean J Urol.
  • 2012 Mar;53(3):178-183.
PURPOSE: To compare the efficacy and safety of Sulosin D (PACIFICPHARMA, Korea) and Harnal D (ASTELLAS PHARMA KOREA, Korea) in treating patients with lower urinary tract symptoms associated with benign...
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