• Journal of Pharmaceutical Investigation
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• v.34 no.1
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• pp.57-71
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• 2004

The objective of this study was to provide a better understanding of SUPAC-IR and its application in handling postapproval changes to immediate release solid oral dosage forms. Originally, SUPAC-IR was aimed at reducing the regulator burdern of the industry when they were making postapproval changes, but still at maintaining the formulation quality and performance of a drug product. The postapproval changes that were covered under SUPAC-IR included variations in the components ad composition of formulation, the site of manufacturing, batch size, manufacturing equipment, and manufacturing process. The guidance defined levels of changes, based on the likelihood of risk ocurrence and potential impact of postapproval changes upon the safety and efficacy of a drug product I suggested what a type of fing report should be submitted to the FDA for each level of change. Chemist, manufacturing, and control tests to be executed were also recommended for each change level The important tests specified in the guidance included batch release, stability, in vitro dissolution, and in vivo bioequivalence tests. However, there have been strong demands on revising the current SUPAC-IR in order to resolve some issues and to improve its usefulness in evaluating postapproval changes to immediate release solid oral dosage forms. In particular, the rigorous requirement of case C dissolution test and the definition of batch size were challenged by both academia and the industry. A revision work was in progress to reflect these inputs and to expand the utility of SUPAC-IR. As a result of these concerted efforts, an updated 2nd version of SPAC-IR would be likely to be issued ver soon to the public.

• Tuberculosis and Respiratory Diseases
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• v.73 no.3
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• pp.143-150
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• 2012

Background: The release of interferon-gamma (IFN-${\gamma}$) by T lymphocytes increases after rechallenge with Mycobacterium tuberculosis antigen, especially, at a localized site of tuberculosis (TB) infection. We aimed to compare the clincial efficacy of two commercial IFN-${\gamma}$ release assays from pleural fluid for the diagnosis in tuberculous pleurisy. Methods: We performed T-SPOT.TB and QuantiFERON-TB Gold tests simultaneously on pleural fluid and peripheral blood samples from patients with pleural effusion, in South Korea, an area with intermediate TB burden. Results: Thirty-six patients were enrolled prospectively, and tuberculous pleurisy was found in 21 patients. Both the numbers of IFN-${\gamma}$ secreting T cells and the concentration of IFN-${\gamma}$ were greater in the pleural tuberculous group, comparing with the non-tuberculous group. Moreover, in the tuberculous group, there was a significant difference in IFN-${\gamma}$ producing spot-forming cells using the T-SPOT.TB method between pleural fluid and peripheral blood. The receiver operating characteristic (ROC) curve, was the greatest for pleural fluid T-SPOT.TB test, followed by peripheral blood T-SPOT.TB test, peripheral blood QuantiFERON-TB Gold test, and pleural fluid QuantiFERON-TB Gold test (area under the ROC curve of 0.956, 0.890, 0.743, and 0.721, respectively). The T-SPOT.TB assay produced less indeterminate results than did QuantiFERON-TB Gold assay in both pleural fluid and peripheral blood. Conclusion: These findings suggest that the pleural fluid T-SPOT.TB test could be the most useful test among the IFN-${\gamma}$ release assays for diagnosing tuberculous pleurisy in an area with an intermediate prevalence of TB infection.

• Applied Chemistry for Engineering
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• v.29 no.2
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• pp.147-154
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• 2018

Currently, to overcome low therapeutic efficiencies and side effects of anticancer agents, the study of drug carrier based on polymers have been consistently investigated. Although the traditional drug carrier based on polymers displayed an excellent result and significant progress, there has been a problem with the side effect and low therapeutic efficiency because of the premature drug release before reached to the targeted region by the low stability in blood stream and sustained drug release. In this review article, to improve the problem of inefficient drug release, methods were suggested, which can maximize the therapeutic efficiency by increasing the stability in the blood stream and triggering drug release at the target site by introducing a stimuli-responsive substance to the non-toxic and biocompatible natural polymer chitosan.

• Korean Journal of Environmental Biology
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• v.32 no.4
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• pp.327-334
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• 2014

Emission reduction of $CH_4$ (methane gas) from rice paddy soil is a very important measure for climate change mitigation in agricultural sector. In this study, we investigated the changes in crop yield and $CH_4$ emissions in response to application of biochar and fertilizers. The experimental site is located in Hwasung, Kyunggido and experimental design is the split-plot method with three replicates. Treatments included rice straw (RS) and biochar (BC) amendments nested with the conventional NPK fertilizer (NPK) and slow release fertilizer (SRF). Control was also prepared with the soil with the conventional NPK fertilization with no amendment. Measurement of $CH_4$ emission was conducted during the growing season of 2014 using a dynamic chamber method. The results showed that application of rice straw increased daily $CH_4$ emission rate by 15%, while application of biochar reduced daily $CH_4$ emission rate by 38%. When we combined biochar application with slow release fertilizer, $CH_4$ emission was reduced by 45%. Further, the crop yield was also increased in all treatments compared with the control except for the treatment of rice straw application with slow release fertilizer. Overall results imply that biochar amendment to agricultural soil can be an effective strategy to decrease annual $CH_4$ emission with no reduction in crop yield.

• Korean Journal of Agricultural and Forest Meteorology
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• v.6 no.3
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• pp.177-182
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• 2004

A chill unit has been used to estimate chilling requirement for dormancy release and risk of freezing damage. A system that calculates chill units was developed to obtain site-specific estimates of dormancy release date for grapes and evaluated in Baekgu myun near Kimje City, Chunbuk, Korea from September 2002 to March 2003. The system utilized daily minimum and maximum temperature maps generated from spatial interpolation with temperature correction for topography. Hourly temperature was temporally interpolated from the daily data using a sine-exponential equation (Patron and Logan, 1981). Hourly chill units were determined from sigmoid, reverse sigmoid, and negatively increasing sigmoid functions based on temperature ranges and summed for 24 h. Cumulative daily chill units obtained from measurements did not increase until 20 October 2002, which was used as a start date for accumulation to estimate the dormancy release date. As a result, a map of dormancy release date in the study area was generated, assuming 800 chill units as a threshold for the chilling requirement. The chill unit accumulation system, implemented using Microsoft Visual Basic and C++ (Microsoft, Redmond, WA, USA), runs in the Windows environment with ArcView (ESRl Inc., Redlands, CA, USA).

• Nuclear Engineering and Technology
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• v.42 no.1
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• pp.17-36
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• 2010

In this study, we compare the mass release rates of radionuclides(1) from waste forms arising from the KIEP-21 pyroprocessing system with (2) those from the directly-disposed pressurized-water reactor spent fuel, to investigate the potential radiological and environmental impacts. In both cases, most actinides and their daughters have been observed to remain in the vicinity of waste packages as precipitates because of their low solubility. The effects of the waste-form alteration rate on the release of radionuclides from the engineered-barrier boundary have been found to be significant, especially for congruently released radionuclides. the total mass release rate of radionuclides from direct disposal concept is similar to those from the pyroprocessing disposal concept. While the mass release rates for most radionuclides would decrease to negligible levels due to radioactive decay while in the engineered barriers and the surrounding host rock in both cases even without assuming any dilution or dispersal mechanisms during their transport, significant mass release rates for three fission-product radionuclides, $^{129}I$, $^{79}Se$, and $^{36}Cl$, are observed at the 1,000-m location in the host rock. For these three radionuclides, we need to account for dilution/dispersal in the geosphere and the biosphere to confirm finally that the repository would achieve sufficient level of radiological safety. This can be done only after we have known where the repository site would by sited. the footprint of repository for the KIEP-21 system is about one tenth of those for the direct disposal.

• Journal of Veterinary Science
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• v.25 no.2
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• pp.30.1-30.16
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• 2024

Background: Biofilms, such as those from Staphylococcus epidermidis, are generally insensitive to traditional antimicrobial agents, making it difficult to inhibit their formation. Although quercetin has excellent antibiofilm effects, its clinical applications are limited by the lack of sustained and targeted release at the site of S. epidermidis infection. Objectives: Polyethylene glycol-quercetin nanoparticles (PQ-NPs)-loaded gelatin-N,O-carboxymethyl chitosan (N,O-CMCS) composite nanogels were prepared and assessed for the on-demand release potential for reducing S. epidermidis biofilm formation. Methods: The formation mechanism, physicochemical characterization, and antibiofilm activity of PQ-nanogels against S. epidermidis were studied. Results: Physicochemical characterization confirmed that PQ-nanogels had been prepared by the electrostatic interactions between gelatin and N,O-CMCS with sodium tripolyphosphate. The PQ-nanogels exhibited obvious pH and gelatinase-responsive to achieve on-demand release in the micro-environment (pH 5.5 and gelatinase) of S. epidermidis. In addition, PQ-nanogels had excellent antibiofilm activity, and the potential antibiofilm mechanism may enhance its antibiofilm activity by reducing its relative biofilm formation, surface hydrophobicity, exopolysaccharides production, and eDNA production. Conclusions: This study will guide the development of the dual responsiveness (pH and gelatinase) of nanogels to achieve on-demand release for reducing S. epidermidis biofilm formation.

• Korean Journal of Plant Tissue Culture
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• v.27 no.5
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• pp.375-377
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• 2000

It is now generally accepted that a phosphoinositide cycle is involved in the transduction of a variety of signals in plant cells. In animal cells, the hydrolysis of phosphatidyl-4,5-bisphosphate catalysed by phosphatidylinositol - specific phospholipase C yields to D-myo-inositol - 1,4,5-trisphosphate and diacylglycerol, which are well known second messengers. The binding of InsP$_3$to a receptor located on the endoplasmic reticulum triggers a calcium release from the endoplasmic reticulum. We have detected and partially characterised key components of phosphoinositide signaling. First, tobacco microsomal fraction and plasma membrane PI-PLC. Consecutively, using a radioligand binding assay we have identified a $Ca^{2+}$ -dependent high affinity InsP$_3$binding site in microsomal membrane fraction vesicle preparation and then we have measured inositol-1,4,5-trisphosphate induced calcium release from tobacco microsomal fraction. These findings suggest that phosphoinositide signaling system is present and operates in the tobacco suspension culture.e.

• Journal of Pharmaceutical Investigation
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• v.22 no.1
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• pp.1-10
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• 1992

The use of erythrocyte as drug carrier has been reviewed, Carrier erythrocytes have proven to offer many advantages for delivery of therapeutic agents, especially in the treatment of inherited enzyme deficiency and cancer. Carrier erythrocytes are biodegradable and nonimmunogenic. Encapsulated drugs may be protected from premature degradation, inactivation and excretion. Carrier erythrocytes may be used as a slow-release system. Targeting of encapsulated drugs directly to a site of action is another possibility. Methods for encapsulating drugs into erythrocytes, the fate of carrier erythrocytes in vivo, the strategies of targeting carrier erythrocytes to special organs and in vivo applications of erythrocytes have been discussed. The encapsulation of drugs in erythrocytes has shown attractive possibilites in future use.

• Proceedings of the Safety Management and Science Conference
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• 2006.11a
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• pp.499-507
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• 2006

The tower cranes are widely used in very useful construction machine the sites of constructing high-structure and have a structural sensitiveness. Therefore, the accidents have often happened due to the deficiency of laborer's understanding md lack of safety of structure. Till now, as we have research and studied above, we can properly protect accidents by construction equipments particularly crane as well as most disasters which occur frequently in construction site. The goal of this study is the safety inspection model of the tower crane a construction site, which preventible the collapse accident of tower crane which is constructed by using the correcting frame. In order to accomplish the goal of this study, the field survey, the reference investigation and the structure analysis were performed for the collapse accident of tower nine using the correcting data. This study will be proposed a build-up solutions about operating and release of safety constructions and researched about software safety estimation. Also, preventing safety problems of Tower Crane Construction site as applying safety estimation program and laws and regulations. As a result, The real time control of tower crane inspection system is implemented by to illustrate the application of the adopted optimal design model.