- Therapeutic Equivalence and Bioequivalence
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Shin SG, Sohn DR
- KMID: 2348701
- J Korean Med Assoc.
- 1999 Aug;42(8):775-780.
- doi: 10.5124/jkma.1999.42.8.775
No abstract available. -
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- Simulation of the AUC Changes after Generic Substitution in Patients
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Yim DS
- KMID: 1794399
- J Korean Med Sci.
- 2009 Feb;24(1):7-12.
- doi: 10.3346/jkms.2009.24.1.7
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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- Bioequivalence test of two ciprofloxacin tablet preparations using high performance liquid chromatography
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Kim SY, Cho YJ, Sung KW, Kim JH, Kim ON, Lee SB
- KMID: 1699654
- Korean J Infect Dis.
- 1991 Nov;23(4):271-278.
No abstract available. -
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- Bioequivalence Study of CIPOL-N(R) (Cyclospoorine Microemulsion Preparation) in Healthy Adults
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Park MS, Yu NC, Na DR, Kim YS, Kim KH
- KMID: 2198904
- J Korean Soc Transplant.
- 1997 May;11(1):109-118.
No abstract available. -
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- A Multi-centric Bioequivalence Trial in Ph+ Chronic Myeloid Leukemia Patients to Assess Bioequivalence and Safety Evaluation of Generic Imatinib Mesylate 400 mg Tablets
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Arora R, Sharma M, Monif T, Iyer S
- KMID: 2344086
- Cancer Res Treat.
- 2016 Jul;48(3):1120-1129.
- doi: 10.4143/crt.2015.436
PURPOSE: This study was designed to characterize the pharmacokinetic profile and to assess bioequivalence of the sponsor's test formulation (imatinib mesylate 400 mg tablets) with an innovator product (Gleevec 400... -
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- Pharmacodynamic Comparison of Two Formulations of Voglibose 0.3-mg Tablet
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Kim MJ, Lim HS, Cho SH, Bae KS
- KMID: 2334543
- J Korean Soc Clin Pharmacol Ther.
- 2013 Jun;21(1):34-40.
BACKGROUND: Voglibose, an inhibitor of alpha-glucosidase of the small intestine brush border, is used to treat type 2 diabetic patients. Bioequivalence test based on pharmacokinetic parameters is difficult because voglibose... -
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- Bioequivalence data analysis for the case of separate hospitalization
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Bae KS, Kang SH
- KMID: 2386766
- Transl Clin Pharmacol.
- 2017 Jun;25(2):93-100.
- doi: 10.12793/tcp.2017.25.2.93
A bioequivalence study is usually conducted with the same-day drug administration. However, hospitalization is occasionally separated for logistical, operational, or other reasons. Recently, there was a case of separate hospitalization... -
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- Modern Methods for Analysis of Antiepileptic Drugs in the Biological Fluids for Pharmacokinetics, Bioequivalence and Therapeutic Drug Monitoring
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Kang J, Park YS, Kim SH, Kim SH, Jun MY
- KMID: 2285410
- Korean J Physiol Pharmacol.
- 2011 Apr;15(2):67-81.
- doi: 10.4196/kjpp.2011.15.2.67
Epilepsy is a chronic disease occurring in approximately 1.0% of the world's population. About 30% of the epileptic patients treated with availably antiepileptic drugs (AEDs) continue to have seizures and... -
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- The Problems of Nonproprietary Names Prescription
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Shin ST
- KMID: 2185726
- J Korean Med Assoc.
- 2008 Feb;51(2):98-102.
- doi: 10.5124/jkma.2008.51.2.98
The government is now operating a pilot project of generic prescription in the National Medical Center and planning to execute it after analyzing the results. The aims of changing Brand... -
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- Bioequivalence Test and Its Significance
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Kim KH
- KMID: 2347652
- J Korean Med Assoc.
- 2002 Jan;45(1):65-72.
- doi: 10.5124/jkma.2002.45.1.65
Bioequivalence is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes... -
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- On comparison of SAS codes with GLM and MIXED for the crossover studies with QT interval data
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Choi K, Hong T, Lee J
- KMID: 2050940
- Transl Clin Pharmacol.
- 2014 Dec;22(2):78-82.
- doi: 10.12793/tcp.2014.22.2.78
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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- Comparative Study of Captopril Tablets on the Bioavailability and the Time Course of Plasma Angiotensin-Converting Enzyme Inhibition
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Jang IJ, Lee JB, Earm JH, Shin JG, Shin SG, Park CW, Han JS, Kim S, Lee JS
- KMID: 1938110
- Korean Circ J.
- 1990 Sep;20(3):452-462.
- doi: 10.4070/kcj.1990.20.3.452
Captopril tablets of two different producers were tested for bioequivalence as well as therapeutic equivalence. The pharmacokinetics, the time course of plasma angiotensin-converting enzyme inhibition, and the changes of systolic... -
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- Comparison of Parametric and Bootstrap Method in Bioequivalence Test
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Ahn BJ, Yim DS
- KMID: 1982570
- Korean J Physiol Pharmacol.
- 2009 Oct;13(5):367-371.
- doi: 10.4196/kjpp.2009.13.5.367
The estimation of 90% parametric confidence intervals (CIs) of mean AUC and Cmax ratios in bioequivalence (BE) tests are based upon the assumption that formulation effects in log-transformed data are... -
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- Bioequivalence of the pharmacokinetics between two formulations of 0.2 mg tamsulosin hydrochloride in healthy subjects
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Park SI, Rhee SJ, Jang IJ, Yu KS, Yim SV, Kim BH
- KMID: 2148855
- Transl Clin Pharmacol.
- 2015 Jun;23(1):21-25.
- doi: 10.12793/tcp.2015.23.1.21
Tamsulosin is an effective therapeutic option for lower urinary tract symptoms, as it selectively blocks alpha1A- and alpha1D-adrenoceptors in the bladder and prostate. The purpose of this study was to... -
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- Pharmacokinetic comparison of two levofloxacin 100-mg tablet formulations and determination of time point appropriately reflecting its area under the curve
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Park KR, Jang K, Lee S, Yu KS, Kim BH, Yim SV
- KMID: 2290474
- Transl Clin Pharmacol.
- 2016 Jun;24(2):84-89.
- doi: 10.12793/tcp.2016.24.2.84
Levofloxacin is a broad-spectrum antibiotic with activity against gram-positive and -negative bacteria. This study compared the pharmacokinetics (PK) and evaluated the bioequivalence of two levofloxacin 100-mg tablet formulations. An open,... -
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- Evaluation of bioequivalence of two enrofloxacin formulations after intramuscular administration in goats
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Aboubakr M
- KMID: 1991774
- Korean J Vet Res.
- 2013 Jun;53(2):77-82.
The present study was planned to evaluate the bioequivalence of two commercial formulations of enrofloxacin, which have been marketed as 10% injectable solution after intramuscular administration at a single dose... -
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- Screening study for genetic polymorphisms affecting pharmacokinetics of simvastatin
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Im S, Kim BH, Lee K, Kwack K, Yim SV
- KMID: 2383599
- Transl Clin Pharmacol.
- 2016 Mar;24(1):43-54.
- doi: 10.12793/tcp.2016.24.1.43
Simvastatin reduces plasma cholesterol by inhibiting HMG-CoA reductase (HMGR) and is widely used in the treatment of hypercholesterolemia. To screening the possible genetic factors affecting the pharmacokinetics (PK) of simvastatin,... -
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- Lack of bioequivalence of two oxytetracycline formulations in the rabbit
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Chong W, Kim YJ, Kim SD, Han SK, Ryu PD
- KMID: 1101571
- J Vet Sci.
- 2002 Mar;3(1):25-30.
Oxytetracycline (OTC) has been used for over 40 years in veterinary medical field. Various forms of oxytetracycline preparations have been marketed, but little information is available on the bioequivalence of... -
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- Systematic Review on Clinical Equivalence of Generic and Brand-name Drugs in Statin Therapy
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Shim H, Lee IH
- KMID: 2387591
- Korean J Clin Pharm.
- 2017 Jun;27(2):105-112.
- doi: 10.24304/kjcp.2017.27.2.105
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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- A post hoc analysis of intra-subject coefficients of variation in pharmacokinetic measures to calculate optimal sample sizes for bioequivalence studies
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Chung I, Oh J, Lee S, Jang IJ, Lee Y, Chung JY
- KMID: 2406999
- Transl Clin Pharmacol.
- 2017 Dec;25(4):179-182.
- doi: 10.12793/tcp.2017.25.4.179
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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