• Title/Summary/Keyword: Clinical pharmacology

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Rapid Determination of Imatinib in Human Plasma by Liquid Chromatography-Tandem Mass Spectrometry: Application to a Pharmacokinetic Study

  • Yang, Jeong Soo;Cho, Eun Gi;Huh, Wooseong;Ko, Jae-Wook;Jung, Jin Ah;Lee, Soo-Youn
    • Bulletin of the Korean Chemical Society
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    • v.34 no.8
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    • pp.2425-2430
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    • 2013
  • A simple, fast and robust analytical method was developed to determine imatinib in human plasma using liquid chromatography-tandem mass spectrometry with electrospray ionization in the positive ion mode. Imatinib and labeled internal standard were extracted from plasma with a simple protein precipitation. The chromatographic separation was performed using an isocratic elution of mobile phase involving 5.0 mM ammonium formate in water-5.0 mM ammonium formate in methanol (30:70, v/v) over 3.0 min on reversed-stationary phase. The detection was performed using a triple-quadrupole tandem mass spectrometer in multiple-reaction monitoring mode. The developed method was validated with lower limit of quantification of 10 ng/mL. The calibration curve was linear over 10-2000 ng/mL ($R^2$ > 0.99). The method validation parameters met the acceptance criteria. The spiked samples and standard solutions were stable under conditions for storage and handling. The reliable method was successfully applied to real sample analyses and thus a pharmacokinetic study in 27 healthy Korean male volunteers.

The Study on the Formative Process of Soeumin Pharmacology -Focused on Gabobon and Sinchukbon- (소음인(少陰人) 약리(藥理)의 형성과정(形成過程) 관한 연구(硏究) -갑오본(甲午本)과 신축본(辛丑本)을 중심으로-)

  • Han, Kyung-Suk;Park, Seong-Sik
    • Journal of Sasang Constitutional Medicine
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    • v.18 no.2
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    • pp.15-24
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    • 2006
  • 1. Objectives This paper was written in order to understand the formative process of Soeumin pharmacology. 2. Methods Souemin pharmacology was analysed with pathology and new prescription in Gabobon(甲午本) and Sinchukbon(辛丑本) of ${\ulcorner}$Dongyi Suse Bowon${\Ircorner}$. 3. Results and Conclusions Soeumin is charactrized to much output of kidney and a little input of speen in sight of ingestive food(水穀). So deficiency of YangQi is a peculiarity of pathology and ascending-Qi is a basic pharmacology. The pharmacology in the exterior disease of Soeumin is built up to base on the old prescription of previous text in Gabobon. Ascending-Yang is the basic pharmacology of Sinchukbon and prescription is summarized to base on the Kyuji-tang. So new prescriptin of Chungoongkyuji-tang and Hwangkikyuji-tang is made by combine Kyuji-tang with Koongkihyangso-san and Bojoongikki-tang. The pharmacology in the interior disease of Soeumin is built up to devide to the weakness of Stomach-Qi, dyspepsia and invasion of cold-Qi. Descending Yin is the basic pharmacology of Sinchukbon and prescription is summarized to base on the Yijoong-tang. Sokunjoong-tang's pharmacology of abdominal pain is newly added and applided to Baekhaoyijoong-tang and Kwankyuboojayijoong-tang. The discourse of the symptoms and diseases at the Sasang Constitutional Medine is built up to base on the previous text in Gabobon and base on clinical experience in Sinchukbon. So clinical experience is the power of summarizing the pharmacology and escaping the previous pharmacology.

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Toxicokinetics of paraquat in Korean patients with acute poisoning

  • Kim, Hak-Jae;Kim, Hyung-Ki;Lee, Hwayoung;Bae, Jun-Seok;Kown, Jun-Tack;Gil, Hyo-Wook;Hong, Sae-Yong
    • The Korean Journal of Physiology and Pharmacology
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    • v.20 no.1
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    • pp.35-39
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    • 2016
  • To conduct a kinetic study of paraquat (PQ), we investigated 9 patients with acute PQ intoxication. All of them ingested more than 20 ml of undiluted PQ herbicide to commit suicide and arrived at our hospital early, not later than 7 h after PQ ingestion. The urine dithionite test for PQ in all of the nine patients was strongly positive at emergency room. Blood samples were obtained every 30 min for the first 2~3 h and then every 1 or 2 h, as long as the clinical progression was stable among the patients for 30 h after PQ ingestion. The area under the plasma concentration-time curve ($AUC_{inf}$), which was extrapolated to infinity, was calculated using the trapezoidal rule. Toxicokinetic parameters, such as the terminal elimination half-life, apparent oral clearance, and apparent volume of distribution ($V_d/F$) were calculated. The maximum PQ concentration ($C_{max}$) and the time to reach maximum PQ concentration ($T_{max}$) were also obtained. Plasma PQ concentrations in nine patients were well described by a bi-exponential curve with a mean terminal elimination half-life of $13.1{\pm}6.8h$. $C_{max}$ and $AUC_{inf}$ were $20.8{\pm}25.7mg/l$ and $172.5{\pm}160.3h{\cdot}mg/l$, respectively. Apparent volume of distribution and apparent oral clearance were $50.9{\pm}61.3l/kg$ and $173.4{\pm}111.2l/h$, respectively. There were a significant correlation (r=0.84; p<0.05) between the PQ amount ingested and $C_{max}$. $AUC_{inf}$ also showed a significant correlation (r=0.83; p<0.05) with the PQ amount ingested. These correlations provide evidence that PQ has dose-linear toxicokinetic characteristics.

Safety, High Quality, Confidence of Kaneka CoQ10

  • Fujii, Kenji
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 2006.11a
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    • pp.139-145
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    • 2006
  • Kaneka Corporation (Kaneka) has been manufacturing CoQ10 under GMP regulation since 1977. Kaneka has a sophisticated quality control system and has been supplying high quality CoQ10 materials to the worldwide customers (Kaneka CoQ10) for about 30 years. Kaneka CoQ10 is characterized by a lot of safety data, which are derived from clinical trials with healthy volunteers (single-dose and 4-week multi-dose safety studies), animal studies (13-week sub-chronic study in dogs and 52-week chronic study in rats), three types of mutagenicity test, six type of skin irritation test (for cosmetics), and others. The risk assessment of CoQ10 was performed by Council for Responsible Nutrition (USA). They reviewed many of available clinical data including clinical trials using Kaneka Q10, and concluded that the upper level for supplements (ULS) of CoQ10 is 1,200 mg/day (Hathcock and Shao. 2006, Regulatory Toxicology and Pharmacology, 45, 282 - 288).

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AMP-activated protein kinase: An emerging target for ginseng

  • Jeong, Kyong Ju;Kim, Go Woon;Chung, Sung Hyun
    • Journal of Ginseng Research
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    • v.38 no.2
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    • pp.83-88
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    • 2014
  • The adenosine monophosphate (AMP)-activated protein kinase (AMPK) is a key sensor of cellular energy. Once activated, it switches on catabolic pathways generating adenosine triphosphate (ATP), while switching off biosynthetic pathways consuming ATP. Pharmacological activation of AMPK by metformin holds a therapeutic potential to reverse metabolic abnormalities such as type 2 diabetes and nonalcoholic fatty liver disease. In addition, altered metabolism of tumor cells is widely recognized and AMPK is a potential target for cancer prevention and/or treatment. Panax ginseng is known to be useful for treatment and/or prevention of cancer and metabolic diseases including diabetes, hyperlipidemia, and obesity. In this review, we discuss the ginseng extracts and ginsenosides that activate AMPK, we clarify the various mechanisms by which they achieve this, and we discuss the evidence that shows that ginseng or ginsenosides might be useful in the treatment and/or prevention of metabolic diseases and cancer.

Five years of the CiPA project (2013-2018) - what did we learn?

  • Yim, Dong-Seok
    • Translational and Clinical Pharmacology
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    • v.26 no.4
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    • pp.145-149
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    • 2018
  • Cases of drug-induced QT prolongation and sudden cardiac deaths resulted in market withdrawal of many drugs and world-wide regulatory changes through accepting the ICH guidelines E14 and S7B. However, because the guidelines were not comprehensive enough to cover the electrophysiological changes by drug-induced cardiac ion channel blocking, CiPA was initiated by experts in governments and academia in the USA, Europe, and Japan in 2013. Five years have passed since the launch of the CiPA initiative that aimed to improve the current ICH guidelines. This report reviews the current achievements of the CiPA initiative and explores unresolved issues.