Earticle

Polymeric aggregates formed during the manufacturing process of intravenous immunoglobulin (IVIG), as a result of protein interactions and further promoted by external factors such as pH shifts, temperature changes, or mechanical agitation can activate the complement system, potentially leading to severe adverse reactions. To mitigate such risks, the anticomplementary activity (ACA) test is employed to evaluate the safety of IVIG by measuring complement consumption following exposure to guinea pig complement. However, the ACA test described in the Korean Minimum Requirements for Biological Products differs from internationally recognized regulatory methods, highlighting the need for harmonization. This study aimed to validate the ACA test based on the European Pharmacopoeia and to establish an internationally harmonized protocol. Method validation confirmed that all analytical parameters met the required criteria. Following validation, the method was applied to assess ACA levels in five IVIG products, with testing conducted across three laboratories. The ACA levels ranged from 7.10% to 29.08%, all within the specified limits. This study provides a foundation for adopting the European Pharmacopoeia-based ACA test for national lot release and quality control of IVIG products. Moreover, it demonstrates the method’s applicability across various IVIG products and supports the global harmonization of testing practices, thereby enhancing international competitiveness.

The intestinal microbiota, an invisible organ supporting a host’s survival, has essential roles in metabolism, immunity, growth, and development. Due to the influence of the intestinal microbiota on the biology of an organism, application of such data to wildlife conservation has gained interest. While there is a standard protocol for studying the human intestinal microbiota, an equivalent one for wildlife is still under development. A major challenge is sampling the intestinal microbiota in an effective, unbiased way. Faecal samples are a popular proxy of the intestinal microbiota because collection is non-invasive, convenient, and allows for longitudinal sampling. Yet, it is unclear whether the faecal microbiota is representative of the intestinal microbiota. In amphibians, research on sampling methodology is limited. In this study, we first characterise and compare microbiota (small intestine, large intestine, faeces) of two Hong Kong stream-dwelling frog species: the Lesser Spiny Frog (Quasipaa exilispinosa) and the Hong Kong Cascade Frog (Amolops hongkongensis). We found that both species have similar dominant phyla and families, but diverge in terms of the dominant genera. Second, we assess the performance of faecal microbiota in representing the intestinal microbiota in these two species. By comparing the microbiota between three sample types (small intestine, large intestine, and faeces), we found (1) that microbiota of small and large intestine differs significantly, (2) that faeces are not an appropriate proxy of both intestinal sections, and (3) a set of microbial taxa that significantly differ between sample type. Our study raises caution on equating faecal and intestinal microbiota. The use of faeces can avoid sacrifice an animal, but researchers should avoid over-extrapolation and interpret results carefully.

목적: 본 연구는 HPLC를 이용하여 작약 뿌리 추출물의 pentagalloylglucose을 지표물질로 설정하고 분석법을 확립하여 유효성 검 증을 하였다. 방법: Pentagalloylglucose 분석을 위해 C18컬럼을 이용하여 이동상 용매를 통해 HPLC 분석을 진행하였다. 분석법의 유효성 검증은 특이성, 직선성, 정확도, 정밀도, 검출한계 및 정량한계 등을 통해 분석법의 신뢰성을 검증하였다. 결과: 작약 뿌리 추출물과 pentaglloylglucose 표준용액 간의 HPLC 크로마토그램 및 UV spectrum의 비교를 통해 다르 물질들의 간섭 없이 피크가 분리된 것으로 특이성을 확인하였으며 상관계수(R2)는 0.9999로 매우 우수한 직선성을 관찰되었다. 검량선의 기울기 및 표준편차 를 이용한 검출한계는 0.92 μg/mL였고 정량한계는 2.72 μg/mL으로 확인되었다. 또한, 정확성 분석을 위해 서로 다른 농도 3개를 선정하여 확인한 결과 RSD가 약 0.12-0.50%로 확인되었다. 결론: 이상의 분석결과를 통해 확립된 작약 뿌리 추출물의 지표성분인 pentagalloylglucose의 HPLC 분석법은 적합한 시험법으로 검증되었으며 원료 표준화를 통해 기능성 원료 자료로 활용될 것으로 사료된다.

Purpose: This study established a high-performance liquid chromatography (HPLC) method to standardize pentagalloylglucose as a marker compound in Paeonia lactiflora (P. lactiflora) root extracts. Methods: The analytical procedure for standardizing pentagalloylglucose was optimized using HPLC on a C18 column with a gradient elution of 0.1% trifluoroacetic acid and acetonitrile. The method was validated for specificity, linearity, limit of detection (LOD), limit of quantitation (LOQ), accuracy, and precision. Results: The method demonstrated high linearity, as evident from a correlation coefficient R2 of 0.9999. The LOD and LOQ were 0.92 and 2.78 μg/mL, respectively. Recovery was determined to be in the range of 101.15 ± 0.49–102.30±0.13, with the relative standard deviation (RSD) values between 0.12%–0.50%, indicating high accuracy. Conclusion: The research lays a foundation for the production of functional foods or cosmetics using pentagalloylglucose derived from P. lactiflora root extract.

目的: 本研究采用HPLC方法建立芍药根提取物的五没食子酰葡萄糖作为指标，建立分析方法，并验证其有效 性。方法: 对于五没食子酰葡萄糖分析，使用C18色谱柱通过流动相溶剂进行HPLC分析。通过特异性，线性， 检测极限(LOD)，定量极限(LOQ)验证了分析方法的可靠性。结果: 通过对比芍药根提取物与五没食子酰葡萄糖 标准溶液的HPLC色谱图和紫外光谱，不受其他物质干扰，峰分离，确认了特异性，且线性良好，相关系数(R2) 为0.9999。使用校准曲线的斜率和标准差的检测限为0.92 μg/mL，并且定量限被确认为2.72 μg/mL。另外，选 择3个不同浓度进行精度分析，结果确认RSD约为0.12-0.50%。结论: 通过上述分析结果建立的芍药根提取物指 示成分五没食子酰葡萄糖的HPLC分析方法，经验证是一种合适的检测方法，有望通过原料标准化作为功能性原 料数据。

Background: In the present study, we established an HPLC (high performance liquid chromatography)-analysis method for the determination of marker compounds as a part of the material standardization for the development of health-functional foods from Salvia plebeia R. Br. extract. Methods and Results: The quantitative determination method of hispidulin as a marker compound was optimized by HPLC analysis using a YMC hydrosphere C18 column with a gradient elution system. This method was validated using specificity, linearity, accuracy, and precision tests. It showed a high linearity in the calibration curve with a coefficient of correlation (r2) of 0.999995. The method was fully validated, and was sensitive, with the limit of detection (LOD) at 0.09 ㎍• ㎖−1 and limit of quantification (LOQ) at 0.27 ㎍• ㎖−1. The relative standard deviation (RSD) values of the data from intra- and inter-day precision were 0.05 - 0.22% and 0.32 - 0.42%, respectively, and the intra- and inter-day accuracy of hispidulin were 99.5 - 102.3% and 98.8 - 101.5%, respectively. The average content of hispidulin in Salvia plebeia R. Br. extract was 3.945 ㎎• g−1 (0.39%). Conclusions: These results suggest that the developed HPLC method is very efficient, and that it could contribute to the quality control of Salvia plebeia R. Br. extracts as a functional ingredient in health functional foods.

본 연구는 핵심 갈등관계 주제(CCRT) 방법을 사용하여 대인관계 패턴 질문지(Interpersonal Relationship Pattern Questionnaire)의 타당도를 검증하고자 하였다. 임상가의 평정을 필요로 하는 CCRT 방법과는 달리, 대인관계 패턴 질문지는 자기보고 방식으로 대인관계 패턴을 간편하게 평가할 수 있다는 점에서 그 활용도가 크다. 본 연구에서는 내담자 65명에게 대인관계 패턴 질문지를 실시하였으며 그 중 다양한 범주의 대인관계 패턴을 보이는 15명을 선정하여 그들의 축어록을 CCRT 방법으로 분석하였다. 이렇게 분석된 CCRT 평정 결과를 대인관계 패턴 질문지의 결과와 비교하여 이들 간의 유사성을 살펴보았다. 그 결과, CCRT 방법에서 높게 평정된 소망, 타인반응, 자기반응들이 대인관계 패턴 질문지에서도 높은 점수를 보임을 알 수 있었다. 한편 CCRT에서 가장 많은 빈도수가 나온 핵심 구성요소들의 대인관계 패턴 질문지 평균 점수를 나머지 구성요소들의 평균 점수들과 각각 대응 표본 t 검증한 결과, 소망과 자기반응에서 유의한 차이가 나타났으며 타인반응에서는 유의한 차이가 나타나지 않았다. 타인반응의 내용을 일부 보완한다면 대인관계 패턴 질문지는 핵심 갈등관계 주제의 내용을 반영하는 자기보고식 평정 도구로 유용하게 사용될 수 있을 것으로 보인다

This study is for verifying the validity of the Interpersonal Relationship Pattern Questionnaire (IRPQ), a self-report measure, using the Core Conflictual Relationship Theme(CCRT) method. Among 65 clients who completed the IRPQ, 15 clients showing various relationship pattern categories were selected and their transcripts were judged through the CCRT method. The result of the CCRT method was compared with the result of the same client's IRPQ to identify the similarity. As a result, the main W(wish), RO(response from others) and RS(response of self) of the CCRT method accorded with the IRPQ components. It means that the IRPQ has some reasonable concurrent validity.

Background : Clearly defined competencies are essential for ensuring patient safety and delivering high-quality pharmaceutical care in evolving healthcare systems. While international models?such as the European Common Training Framework and the Austrian Hospital Pharmacist Competency Framework?guide pharmacist development, Korea lacks a unified and validated standard that aligns with its healthcare and edu cational contexts. This study aimed to integrate international frameworks with Korean clinical pharmacy competencies, map existing domestic indicators onto the combined model, and validate the framework through expert consensus. Methods : A two-phase, multi-method approach was employed. Phase 1 involved synthesizing the European and Austrian frameworks and mapping Korean competencies according to the standards set by the Korean Accreditation Council for Pharmacy Education. Phase 2 utilized a four-round Delphi process (July-August 2025) in accordance with ACCORD reporting guidelines. The expert panel consisted of 17 members, including 16 hospital pharmacists and 1 specialist in health professions education. Quantitative assessments applied content validity ratio (CVR), convergence (CVG), and consensus (CSS) indices, while qualitative feedback informed revisions. Results : The mapping identified 44 behavioral indicators in the European framework, 71 in the Austrian framework, and 30 in the Korean framework, with 22 Korean indicators (72%) aligning with international standards. Out of 81 initial items, 61 were retained after Delphi validation, while 20 items?primarily related to physical assessment, pharmacoeconomic principles, research skills, and emerging technologies?were excluded due to low CVR. CVG values (0.25-1.25) and CSS values (0.43-0.92) indicated acceptable convergence and stability. The final framework outlines essential competencies that emphasize evidence-based pharmacotherapy, patient-centered care, and interprofessional collaboration. Conclusion : This study successfully developed and validated a hospital pharmacist behavioral competency framework tailored to the Korean healthcare context. The framework demonstrates strong content validity and expert consensus, serving as a foundational reference for competency-based education, curriculum development, professional training, and performance assessment in hospital pharmacy practice

A simple HPLC method was employed for the determination of pentoxifylline in human serum. After addition of internal standard (IS, 50 uL of 3 ug/mL chloramphenicol methanol solution) into the serum sample, the drug and IS were extracted by dichloromethane. Following a 1-min vortex-mixing and a 15-min centrifugation at 3500 게m, the organic phase was transferred and evaporated to dryness under a vacuum. The residue was reconstituted with 120 of mobile phase and 50 was injected into C18 column with a mobile phase composed of 0.034 M phosphoric acid adjusted to pH 4 with 10 M NaOH and acetonitrile (75:25, v/v). The samples were detected using an ultraviolet detector at 273 nm. The method was simple, specific and validated with a limit of 10 ng/mL. Intra- and inter-day precision and accuracy were acceptable for all quality control samples including the lower limit of quantification. The applicability of this method was evaluated by analysis of human serum after oral administration of a single 400 mg dose to 8 healthy subjects. The pharmacokinetic parameters for pentoxifylline in human subjects were calculated using WinNonlin program. As a result, and were , ng/mL, hr and hr, respectively. Based on the results, this validated method appears to be useful fur the pharmnacokinetic study of pentoxifylline in humans.

The launcher of a hard-kill type APS (Active Protection System) requires rapid and precise driving to target approaching threats after detection. High angular acceleration is required for rapid driving, which requires high energy consumption. However, the sufficient energy storage of the APS is limited due to weight and space constraints. If energy is insufficient during driving, the charged voltage of the capacitor bank may drop below the minimum operating voltage of the drive motor, which may result in problems such as torque insufficiency or saturation of the controller's integrator. Therefore, it is necessary to determine the maximum angular acceleration possible within the available energy and generate a corresponding driving profile. This paper proposes a method for calculating allowable energy and deriving allowable maximum angular acceleration for driving profile, and validates the proposed method through experiments. We established and implemented a method for deriving maximum angular acceleration through experimental methods to account for unknown frictional forces and mechanical errors in the launcher. By applying the proposed method, we confirmed that the system can operate at high speeds stably by reflecting appropriate angular acceleration even during continuous operation. Therefore, it is expected that the application of the proposed method will improve the operating stability of the APS launcher and enable continuous operation at maximum speed within limited energy.

Formulation of the finite element method(FEM) for dynamic interaction between a pantograph and contact wire, including non-linear formulation associated with contact wire stagger in the railway overhead contact line is presented. Penalty method is chosen for modelling contact between a pantograph and contact wire. The formulation is validated by comparing the simulated contact forces with measurements taken from 300 km/h KTX operation.

Packaging process is a special process under the definition of GMP. That is, it shall be managed specially since the state of sterilization and product cannot be checked completely in the following inspection or test after packaging. The special management like this shall be started from the validation. Recently in case of the sterile product, the importance of packaging work process which maintains sterility and protects products together with the sterilization process is being highlighted. However, it is urgent to conduct a study on the guideline which can evaluate the safety and validity of packaging process since it is the actual situation in Korea not only that there is no guideline possible to evaluate the safety and validity of packaging process, but also that there is no practice case which is known widely. Therefore, we would like to develop the guideline which can be utilized at the site by reinterpreting current status on standards and studies in relation to the packaging at home and abroad through this study. Packaging validation may be referred to as the work checking the feasibility for the packed final product whether the process, facility or system functions properly as it was intended to with the objective evidence. This report would like to present practice cases such as various data analyses to perform the IQ (installation qualification), OQ (operation qualification), PQ (performance qualification) and packaging validation. The final objective of this research task is to build the guideline to packaging validation of medical devices which coincides with international standards and to reflect it to the screening and evaluation, etc. for the advancement in GMP operation of the medical device manufacturer. It is expected that the technological level of medical device manufacturer on GMP operation will be enhanced by preparing the guideline to packaging validation and practice standards through this study, and that it will contribute not only to the development of medical device industry, but also to the securement of health and safety of our people.

Currently, fire investigation lack liveliness because they are performed based on photographs taken. Therefore, in this paper, we propose a method utilizing the metaverse to improve the validity of fire investigation. The fire scene was recreated by gathering the point cloud data of the 3D scanner, matching them, and then post-processing the matched data. In addition, a virtual space was created by an engine and VR equipment, with the addition of UI(User interface) and assets, to apply the created point cloud. With this method, it is expected that the validity of fire investigation will improve with a more vivid recreation of the fire scene through the metaverse.

본 연구에서는 김광회 등(2015)의 체육영재의 영재성 검사도구에 대한 타당도를 검증하는 연구로써 이를 위 하여 총 3회에 걸친 지도자 관찰평가를 실시하였다. 이 후 관찰평가 결과의 하위영역(실천지능, 학습지능, 훈련지능) 과 영재 학생들의 체력 및 종목적합률(KOSTASS) 향상도간 상관분석을 실시하였으며 결과는 다음과 같다. 첫째, 종 목별 지도자의 영재성 하위 영역간 상관성은 모든 영역에서 0.8 이상으로 유의한 상관성을 보였다. 둘째, 체육영재성 의 모든 하위영역은 제자리멀리뛰기, 50m 달리기, 사이드스텝 테스트 향상도와 유의한 정적 상관성을 보였다(p<.05). 셋째, 체육영재성의 모든 하위영역은 KOSTASS와 유의한 상관성을 보이지 않았다(p>.05). 이상의 결과는 김광회 등 (2015)이 제시한 영재성 평가도구가 체육영재 학생들의 기초체력 요인의 향상도 수준을 충분히 반영하고 있지 않음 을 의미한다. 하지만 학습과정이 요구되는 체력요인에 대한 상관결과는 체육영재성 평가도구가 학습과정 및 과제습 득 수준을 포함하고 있음을 확인할 수 있었다.

The purpose of this study was to verify the validity of the developed evaluation method for competition intelligence of sport talented children of of Kim et al.(2015). For this purpose, total 3 times of observation by sports leaders were accomplished for evaluation of competition intelligence. After finishing final observation, the correlation between the sub-factors(practice intelligence, learning intelligence, and training intelligence) and gifted students' physical fitness and KOSTASS were examined. First, as the reliability, the correlations between leaders' observation results were significantly higher than 0.8 in all sub-factors. Second, all sub-factors of competition intelligence showed significant positive correlation with in standing jump, 50m dash and side step test improvement(p<.05). Third, all sub-factors showed no significant correlation with KOSTASS(p>.05). These results showed that the evaluation tool by Kim et al.(2015) didn't not fully reflect the improvement level of basic physical fitness factors of the gifted students. However, the results of correlation between physical fitness factors requiring technical learning process showed that the gymnastic gauging tools included learning process and task acquisition level.

Doxorubicin (DXR) is a type of anti-cancer drug called an 'anthracycline glycoside', It works by impairing DNA synthesis, a crucial feature of cell division, and thus is able to target rapidly dividing cells. Doxorubicin is a very serious anti-cancer medication with definite potential to do great harm as well as great good. A liquid chromatography-tandem mass spectroscopy (LC-MS/MS) method was developed to identify and quantify DXR in small-volume biological samples. After the addition of internal standard (IS, daunorubicin methanol solution) into the serum sample, the drug and IS were extracted by methanol. Following vortex for a 1min and centrifugation at 15,000g for 10 min the organic phase was transferred and evaporated under a vacuum. The residue was reconstituted with of mobile phase and was injected into C18 column with mobile phase composed of 0.05M ammonium acetate (0.1 M acetic acid adjusted to pH 3.5) and acetonitrile (40:60, v/v). The flow rate was kept constant at . The ions were quantified in the multiple reaction mode (MRM), using positive ions, on a triple quadrupole mass spectrometer. The lower limits of quantification for Doxorubicin in plasma and small tissues were approximately 0.5 ng/mL and 0.5 ng/mL respectively. Intra- and inter-assay accuracy (% of nominal concentration) and precision (% CV) for all analytes were within 15%, respectively.