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Pharmacodynamic principles and the time course of immediate drug effects

Holford N

This tutorial defines the principles of the concentration - effect relationship which are the basis of pharmacodynamics. The two key parameters of pharmacodynamics are the maximum response (Emax) and the...
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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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Development and validation of analytical method for the determination of radotinib in human plasma using liquid chromatography-tandem mass spectrometry

Seo HB, Cho S, Yoon YR, Yim DS

This study describes the development of an analytical method to determine radotinib levels in human plasma using high performance liquid chromatography (HPLC) coupled with triple quadrupole tandem mass spectrometry (MS/MS)...
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Pharmacokinetics of atorvastatin and sustained-release metformin fixed-dose combination tablets: two randomized, open-label, 2-way crossover studies in healthy male subjects under fed conditions

Choi YK, Park SE, Kim EY, Park HJ, Kim EJ, Song GS, Ghim JL

Two separate studies were conducted to establish bioequivalence (BE) for two doses of atorvastatin/metformin sustained-release (SR) fixed dose combination (FDC) versus the same dosage of the individual component (IC) tablets...
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Post lumbar puncture headache: Case report of a serious adverse event in first-in-human study

Shin W, Kim MK, Kim J, Woo MH, Cho DY, Lim KS

A lumbar puncture can be used to measure the concentrations of drugs and/or pharmacodynamic biomarkers during clinical trials of central nervous system drugs. We report a case of a post...
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Comparison of pharmacokinetics and safety of fixed-dose combination of SKI306X and aceclofenac versus separate tablets in healthy subjects

Meng X, Oh ES, Park MS, Kim D, Kim JH, Kim CO

JOINS (SKI306X) is an herbal anti-arthritic medicine that is widely used with aceclofenac for treating osteoarthritis in Korea. A fixed-dose combination (FDC) tablet containing SKI306X and aceclofenac was developed to...
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Pharmacokinetic drug interaction between atorvastatin and ezetimibe in healthy Korean volunteers

Park J, Kim CO, Jin BH, Yang S, Park MS, Hong T

Atorvastatin and ezetimibe are frequently co-administered to treat patients with dyslipidemia for the purpose of low-density lipoprotein cholesterol control. However, pharmacokinetic (PK) drug interaction between atorvastatin and ezetimibe has not...
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Screening study for genetic polymorphisms affecting pharmacokinetics of talniflumate

Jin LH, Kim BH, Lee JH, Lee K, Kwack K, Yim SV

Talniflumate is a phthalidyl ester of niflumic acid, which has potent analgesic and anti-inflammatory effects and is widely used to treat inflammatory disorders, such as rheumatoid arthritis. To screen the...
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Development of a simple and sensitive HPLC-MS/MS method for determination of diazepam in human plasma and its application to a bioequivalence study

Kim DH, Cho JY, Chae SI, Kang BK, An TG, Shim WS, Noh YS, Hwang SJ, Chung EK, Lee KT

We developed a simple, sensitive, and effective ultra-performance liquid chromatography/tandem mass spectrometry (HPLC-MS/MS) method with an electrospray ionization (ESI) interface in multiple reaction monitoring (MRM) and positive ion modes to...
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