• Korean Journal of Clinical Pharmacy
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• v.31 no.1
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• pp.53-60
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• 2021

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

• Proceedings of the Korean Society of Applied Pharmacology
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• 2001.11a
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• pp.109-109
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• 2001

The present study was done to investigate the relationship between Kupffer cells and alteration of cytochrome P-450 (CYP)-dependent drug metabolizing enzyme activities during polymicrobial sepsis. Male rats were subjected to polymicrobial sepsis by cecal ligation and puncture (CLP) followed by fluid resuscitation. The gadolinium chloride (GdC1$_3$, 10 mg/kg), blocker of Kupffer cells, was pretreated intravenously at 48 h and 24 h prior to the induction of CLP. All assay parameters were determined at 24 h after CLP or sham operation. In CLP-treated rats, the mortality rate of animals increased to 50% and serum alanine (ALT) and aspartate aminotransferase (AST) levels also significantly elevated. However, this increase was not suppressed by GdC1$_3$ pretreatment. Microsomal lipid peroxidation markedly increased after CLP operation. This increase was significantly attenuated by pretreatment. Total cytochrome P-450 content and NADPH-cytochrome P-450 reductase activity were not changed after CLP operation, but GdC1$_3$pretreatment reduced total cytochrome P-450 content, The hepatic microsomal CYP 1A1, 1A2, 2Bl and 2El activities in CLP-induced rats were also not significantly different from sham-operated rats. However, GdC1$_3$pretreatment showed a moderate increase in CYP1A1 and 1A2 activities. Our findings suggest that Kupffer cells may be partly responsible for producing hepatocellular dysfunction during sepsis.

• Korea Journal of Hospital Management
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• v.7 no.2
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• pp.37-51
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• 2002

It has been 2 years since the implementation of the separation of prescription and drug dispensing policy. This study analyzes the effects of the policy on the job contents and personnel structure of hospital pharmacy. The main purposes of the analysis are to determine if the policy has causes the increase of professional activities of pharmacists in hospital and to investigate whether the hospital pharmacy is equipped with enough manpower to provide high quality pharmaceutical service as intended by the policy. The level of professionality of pharmacists' activities is measured by the number of activities of direct involvement in inpatient care such as participation in patient rounding, medication consultation, the number of hospital committee the pharmacists involved and the number of continuous education pharmacists took. The adequacy of personnel structure to provide high quality pharmaceutical care is measured by the level of compliance to the governmental standard of hospital pharmacy personnel. In order to collect the data, surveys were performed for two periods: year 1999 (before the implementation of the policy) and year 2001 (after the implementation of the policy). The results show that the pharmacists' participation in inpatient rounding decreased and that the inpatient medication history management activities, operation of ward pharmacy, participation in hospital committee increased. In personnel structure, the average number of pharmacist per hospital decreased and the number of prescription processing per pharmacist increased. Based on the results this study concludes that the professional activities of hospital pharmacists has increased a little and there were structural changes in hospital pharmacy service activities to increase the professionalism in providing care. However, the pharmacy departments were understaffed hampering the strive to increase the provision of professional pharmaceutical service in hospitals.

• Korean Journal of Clinical Pharmacy
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• v.32 no.2
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• pp.93-105
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• 2022

Objectives: This study aimed to identify the opinions of Gyeongsangbuk-do residents on out-of-hours (OOH) pharmacies and to examine the operating experiences of pharmacists who are operating OOH pharmacies in other areas. Methods: Cross-sectional survey was carried out for 1,000 Gyeongbuk residents employing a questionnaire via online or face-to-face, and 82 pharmacists who currently operate OOH pharmacies employing a postal questionnaire. Out of eighty-two, 46 pharmacists replied (response rate 56.1%). Results: As for the necessity of introducing OOH pharmacies in Gyeongsangbuk-do, 84.9% answered more than necessary. 86.1% favored the local government support for OOH pharmacies. The necessity of OOH pharmacies was highly evaluated among participants who experienced to be unable to use medicines or services in out of service hours, regardless of their characteristics or health condition. County residents consistently put a positive opinion for the necessity of OOH pharmacies if they have elderly family member(s), while city residents had significant differences across subgroups depending on their conditions (family members, household economics, health status, etc.). Almost all (95.7%) pharmacist participants highly evaluated the necessity of OOH pharmacies and the majority of them (63.0%) felt satisfied. However, 60.9% of participants have ever considered closing their OOH pharmacy business due to private, business management and professional reasons. Conclusion: This study made suggestions to address anticipated issues for the Gyeongbuk-style OOH pharmacy model.

• Journal of Korean Neurosurgical Society
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• v.64 no.4
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• pp.534-542
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• 2021

Objective : While balanced crystalloid (BC) could be a relevant fluid regimen with buffer system compared with normal saline (NS), there have been no studies on the optimal fluid for surgery of an unruptured intracranial aneurysm (UIA). This study aimed to compare the effects of fluid regimens between NS and BC on the metabolic and clinical outcomes of patients who underwent surgery for UIA. Methods : This study was designed as a propensity score matched retrospective comparative study and included adult patients who underwent UIA clipping. Patient groups were categorized as NS and BC groups based on the types of pre-operative fluid and the amount of fluid administered during surgery. The primary outcomes were defined as electrolyte imbalance and acidosis immediately after surgery. The secondary outcomes were the length of stay in the intensive care unit (ICU) and duration from the end of the operation to extubation. Results : A total of 586 patients were enrolled in this study, with each of 293 patients assigned to the NS and BC groups, respectively. Immediately after surgery, serum chloride levels were significantly higher in the NS group. Compared to the NS group, the BC group had lower incidence rates of acidemia (6.5% vs. 11.6%, p=0.043) and metabolic acidosis (0.7% vs. 4.4%, p=0.007). As compared to NS group, BC group had significantly shorter duration from the end of the operation to extubation (250±824 vs. 122±372 minutes, p=0.016) and length of stay in ICU (1.37±1.11 vs. 1.12±0.61 days, p=0.001). Throughout multivariable analysis, use of BC was found to be significant factor for favorable post-operative results. Conclusion : This study showed that the patients who received BC during UIA clipping had lower incidence of metabolic acidosis, earlier extubation and shorter ICU stay compared to those who received NS. Therefore, using BC as a peri-operative fluid can be recommended for patients who undergo surgery for UIA.

• Proceedings of the Korean Society of Applied Pharmacology
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• 1995.04a
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• pp.110-110
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• 1995

This study was carried out to investigate the dose dependent antifibrotic effects of G009, the water-soluble fraction of polysaccharide extracted from Ganoderma lucidum. The experimental hepatic cirrhosis was induced by bile duct ligation/scission (BDL/S) in rats. BDL/S rats in each group were dosed 0.5, 2, 5 or 10mg/rat/day orally for 4 weeks after the operation. Antifibrotic effects were evaluated by serum biochemical values, hydroxyproline contents, and light microscopical histology.

• YAKHAK HOEJI
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• v.41 no.2
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• pp.220-224
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• 1997

This study was carried out to investigate the dose dependent antifibrotic effects of polysaccharide from mycelium of Ganoderma lucidum. The experimental hepatic cirrhosis was induced by bile duct ligation/scission (BDL/S) in rats. BDL/S rats in each group were dosed 0.5 mg, 2.0 mg, 5.0 mg or 10.O mg/rat/day orally for 4 weeks after the operation. Antifibrotic effects were evaluated by serum biochemical values, hydroxyproline contents, and light microscopical histology. The results obtained were as follows: 1) Hydroxyproline contents in liver of 5.0 and 10.0mg polysaccharide-treated BDL/S rats were significantly reduced 2) In serum test, ALT, AST, ALP values in polysaccharide from Ganoderma lucidum-treated group were lower than BDL/S control group 3) The hepatic damage such as hepatocellular necrosis, inflammation, bile duct proliferation and fibrosis was less severe in the livers of 2.0 mg and 5.0 mg polysaccharide-treated rats. These results suggest that polysaccharide from mycelium of Ganoderma lucidum to be a promising agent for the inhibition of hepatic cirrhosis.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.7
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• pp.3071-3074
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• 2014

Background: To investigate the related risk factors of postoperative nosocomial pneumonia (POP) in patients withI-IIIa lung cancer. Methods: Medical records of 511 patients who underwent resection for lung cancer between January 2012 to December 2012 were retrospectively reviewed. Risk factors of postoperative pneumonia were identified and evaluated by univariate and multivariate analyses. Results: The incidence of postoperative pneumonia in these lung cancer patients was 2.9% (15 cases). Compared with 496 patients who had no pneumonia infection after operation, older age (>60), histopathological type of squamous cell carcinoma and longer surgery time (>3h) were significant risk factors by univariate analysis. Other potential risk factors such as alcohol consumption, history of smoking, hypersensitivity, hypertension, diabetes mellitus and so on were not showed such significance in this study. Further, the multivariate analysis revealed that old age (>60 years) (OR 5.813, p=0.018) and histopathological type of squamous cell carcinoma (OR 5.831, p<0.001) were also statistically significant independent risk factors for postoperative pneumonia. Conclusions: This study demonstrated that being old aged (>60 years) and having squamous cell carcinoma histopathological type might be important factors in determining the risk of postoperative pneumonia in lung cancer patients after surgery.

• Journal of the Korea Institute of Information and Communication Engineering
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• v.23 no.9
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• pp.1032-1037
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• 2019

In the existing pharmacy automation system, quantity control was carried out only in the memory without first measuring the quantity of the medicine and during the operation of the facility. As a result, the number of drugs that have already been deducted during operation at the time of a facility error has not been managed. Serious problems are caused by important medicines that need to be managed because of lack of quantity control. In addition, the user had to refill the drug when it was exhausted because the user could not know the amount of the drug outside the facility. When the drug was out of stock, the facility was operating with loss of time to restart and the time to replenish the drug. Thus, in this paper, we designed and applied system to control the quantity of medicines frequently by adding displacement sensors to the robot of the facility.

• Toxicological Research
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• v.32 no.4
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• pp.311-316
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• 2016

Effects of nanoparticles (NPs) on skin corrosion and irritation using three-dimensional human skin models were investigated based on the test guidelines of Organization for Economic Co-operation and Development (OECD TG431 and TG439). EpiDerm$^{TM}$ skin was incubated with NPs including those harboring iron (FeNPs), aluminum oxide (AlNPs), titanium oxide (TNPs), and silver (AgNPs) for a defined time according to the test guidelines. Cell viabilities of EpiDerm$^{TM}$ skins were measured by the 3-(4, 5-dimethylthiazol-2-yl)-2.5-diphenyltetrazolium bromide based method. FeNPs, AlNPs, TNPs, and AgNPs were non-corrosive because the viability was more than 50% after 3 min exposure and more than 15% after 60 min exposure, which are the non-corrosive criteria. All NPs were also non-irritants, based on viability exceeding 50% after 60 min exposure and 42 hr post-incubation. Release of interleukin 1-alpha and histopathological analysis supported the cell viability results. These findings suggest that FeNPs, AlNPs, TNPs, and AgNPs are 'non-corrosive' and 'non-irritant' to human skin by a globally harmonized classification system.