• Food Science and Industry
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• v.42 no.3
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• pp.14-19
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• 2009

• Journal of Pharmaceutical Investigation
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• v.36 no.2
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• pp.137-142
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• 2006

A bioequivalence of Daewoong $Alendronate^{TM}$ (Daewoong Pharmaceutical Co., Ltd., Korea) and $Fosamax^{TM}$ tablets (MSD Korea) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). A single 70 mg dose of sodium alendronate of each medicine was administered orally to 56 healthy male volunteers. This study was performed in a $2\;{\time}\;2$ crossover design. Concentrations of alendronate in the urine were monitored by a high-performance liquid chromatography (HPLC). $A_{et}$ (cumulative urinary excreted amount from time 0 to last sampling interval) was calculated by the accumulation of the urinary excreted alendronate. $U_{max}$ (maximum urinary excretion rate) and $T_{max}$ (time to reach $U_{max}$) were compiled from the urinary excretion rate - time data. Analysis of variance was performed using logarithmically transformed $A_{et}$ and $U_{max}$. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the $A_{et}$ and $U_{max}$ for Daewoong $Alendronate^{TM}/Fosamax^{TM}$ were 0.89-1.12 and 0.82-1.02, respectively. This study demonstrated the bioequivalence of Daewoong $Alendronate^{TM}$ and $Fosamax^{TM}$ with respect to the rate and extent of absorption.

• Proceedings of the KSCN Conference
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• 2005.04a
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• pp.169-169
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• 2005

• Journal of Korean Institute of Industrial Engineers
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• v.39 no.5
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• pp.403-411
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• 2013

The quality of the products/processes has been improved remarkably since robust design (RD) methodology is applied into the practice manufacturing processes. A model building method based on the dual responses methods for multiple and time oriented responses on a drug development process is employed in this paper instead of the previous methods that handle the static nature of data and single response. Subsequently, the optimal solutions of a multiple and time series RD problem are obtained by using the proposed augmented weighted Tchebycheff method that has a significant flexibility on assigning weights. Finally, a pharmaceutical case study associated with a generic drug development process is conducted in order to illustrate the efficient optimal solutions from the proposed model.

• Archives of Pharmacal Research
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• v.26 no.3
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• pp.210-213
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• 2003

Puerariae Flos is a traditional herbal medicine that has long been used as a treatment for colds, diabetes, and hangovers. The herbal medicine contains a wide variety of isoflavones such as kakkalide, tectoridin, and tectorigenin. This study demonstrates that the substances undergo a certain degree of change depending on the storage period by the method of HPLC and $^{13}C-NMR$, and that the HPLC analysis can be used to determine the freshness of Puerariae Flos.

• Proceedings of the PSK Conference
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• 2001.04a
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• pp.109.2-110
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• 2001

• Biomolecules & Therapeutics
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• v.14 no.2
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• pp.110-113
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• 2006

We tested effect of sarcotride A, a bioactive cyclitol derivative from a marine sponge, on membrane potential in C6 glioma cells. Membrane potential was estimated by measuring fluorescence change of DiBAC-loaded glioma cells. Sarcotride A increased membrane potential in a concentration-dependent manner. We tested effects of pertussis toxin, U73122, EIPA, and $Na^+-free$ media on sarcotride A-induced increase of membrane potential to investigate involvement of G proteins, phospholipase C, $Na^+/H^+$ exchanger, and $Na^+$ channels. However, we were not able to observe any significant effect of those pharmacological inhibitors, excluding the involvement of the molecules as candidate targets or signaling molecules of sarcotride A-induced increase of membrane potential. Further investigation is necessary to elucidate action mechanism of sarcotride A.

• Natural Product Sciences
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• v.25 no.1
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• pp.23-27
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• 2019

From the pericarps of Litsea japonica (Thunb.) Jussieu, eighteen butanolide derivatives (1 - 18) were evaluated for their cytotoxic activity against HeLa, HL-60, and MCF-7 cells. Compounds 1-9 with 2-alkylidene-3-hydroxy-4-methylbutanolides structure exhibited cytotoxic activities against cancer-cell lines. Among them, compound 8 (litsenolide $D_2$) exhibited the most potent cytotoxicity against the tested cell lines, including HeLa, HL-60, and MCF-7, with $IC_{50}$ values of $17.6{\pm}1.3$, $4.2{\pm}0.2$, and $12.8{\pm}0.0{\mu}M$, respectively. Compound 8 induced apoptosis in a dose-dependent manner. Annexin V/Propidium Iodide (PI) double staining confirmed that 8 effectively induced apoptosis in MCF-7 cells. To the best of our knowledge, we have reported cytotoxic activity of butanolides from L. japonica against these cancer-cell lines for the first time.

• Proceedings of the Membrane Society of Korea Conference
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• 1996.10a
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• pp.18-21
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• 1996

Virus and DNA removal in bio-drug manufacturing processes has received a great deal of attention in recent years. Removing of a virus using a membrane process is a promising method, because inactivated virus can be removed from the bio-drug and the process can be used as an additional and security inactivation after the method of general heat-inactivation of the virus in the bio-drug. The FDA and the biopharmaceutical industry have recently announced strict guidelines for impurities of virus and DNA contamination. The regulatory guidelines on residual amounts of DNA in mammalian cell culture products require DNA contamination of less than 100 pg/dose. Therefore, permeation and rejection of DNA through the porous membranes have become important in the application of DNA removal in bio-drug manufacturing using membrane technology. In this study, the permeation of DNA and chromatin through regenerated cellulose hollow fibers that have a mean pore diameter of 15 nm was investigated.

• Toxicological Research
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• v.31 no.2
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• pp.137-149
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• 2015

Human hepatocytes, with complete hepatic metabolizing enzymes, transporters and cofactors, represent the gold standard for in vitro evaluation of drug metabolism, drug-drug interactions, and hepatotoxicity. Successful cryopreservation of human hepatocytes enables this experimental system to be used routinely. The use of human hepatocytes to evaluate two major adverse drug properties: drug-drug interactions and hepatotoxicity, are summarized in this review. The application of human hepatocytes in metabolism-based drug-drug interaction includes metabolite profiling, pathway identification, P450 inhibition, P450 induction, and uptake and efflux transporter inhibition. The application of human hepatocytes in toxicity evaluation includes in vitro hepatotoxicity and metabolism-based drug toxicity determination. A novel system, the Integrated Discrete Multiple Organ Co-culture (IdMOC) which allows the evaluation of nonhepatic toxicity in the presence of hepatic metabolism, is described.