Shear stress-induced SIRT1 activation : effects on mitochondrial biogenesis and endothelial senescence

김지석 ProQuest LLC UMI 2016 국내박사

Effects of exercise preconditioning on muscle hypertrophy and mitochondrial remodeling following the subsequent resistance training

이호준 ProQuest LLC UMI 2016 국내박사

Advancement in Analytical Methods for Nitrosamine Impurities Detection in Pharmaceuticals

이남진 아주대학교 일반대학원 2025 국내박사

Nitrosamine impurities have emerged as a major concern in pharmaceutical quality and regulatory compliance due to their recognized genotoxic and carcinogenic risks. Numerous recalls and increased scrutiny by global regulatory agencies have driven the urgent need for reliable, sensitive, and formulation-specific analytical methodologies. While significant progress has been made in the analysis of nitrosamines in conventional solid oral dosage forms such as tablets and capsules, analytical challenges remain for more complex formulations, including semi-solids and sustained-release products. This dissertation aims to advance the current state of nitrosamine impurity testing by developing and validating optimized analytical methods tailored to these under-researched dosage forms. Part I focuses on the simultaneous determination and quantification of 9 nitrosamine impurities (NDMA, NDEA, NMEA (NEMA), NDPA, NDBA, NPIP, NMOR, DIPNA (NDIPA), and EIPNA (NEIPA)) in semi-solid pharmaceutical formulations such as ointments, gels, and creams using a highly sensitive GC-MS/MS method. Semi-solid formulations pose unique analytical challenges due to their high viscosity, complex excipient compositions, and frequent inclusion of volatile aromatic components. These characteristics can interfere with analyte extraction and chromatographic separation. To address these issues, a novel sample preparation method was developed employing phase separation using a combination of solvents-methanol, hexane, water, and dichloromethane to effectively isolate target analytes. A 60-meter GC column was employed to overcome peak co-elution, and method parameters were optimized for each analyte. The method was validated in accordance with ICH guidelines, demonstrating excellent specificity (selectivity), sensitivity, linearity, accuracy, precision, and robustness(solution stability). Recovery studies showed over 80% recovery for all target analytes across various sample types, confirming its applicability to a wide range of pharmaceutical and cosmetic products. This method represents a significant advancement in nitrosamine analysis for semi-solid dosage forms, where no official method currently exists. Part II extends the investigation to sustained-release formulations, which are increasingly used for their pharmacokinetic advantages and patient compliance benefits. These formulations often incorporate cellulose-based excipients such as hydroxy- propylmethyl cellulose, ethyl cellulose, and microcrystalline cellulose that control drug release through gel formation or diffusion barriers. However, these excipients can adversely affect chromatographic analysis by forming viscous gels or releasing microfibers that clog HPLC columns. This study identifies and evaluates critical precautions necessary for accurate HPLC-based evaluation of nitrosamine impurities in such matrices. Through solvent screening and stress testing, it was demonstrated that the use of water-based solvents exacerbated column clogging and peak tailing, while methanol as a non-aqueous solvent significantly mitigated these issues. The modified method enabled reliable detection of nitrosamine impurities at trace levels (ppb range) in challenging sustained release formulations, including sitagliptin-containing products. The analytical procedure was validated and shown to be robust, reproducible, and effective for real-world application. Taken together, this research provides comprehensive analytical solutions for the detection of nitrosamine impurities in complex pharmaceutical formulations. The findings underscore the importance of formulation-specific analytical strategies, not only in method development but also in sample preparation and excipient interaction management. By offering validated, adaptable, and efficient testing platforms for both semi-solid and sustained-release dosage forms, this dissertation contributes significantly to the field of pharmaceutical analysis and regulatory science. The methodologies established herein may serve as reference frameworks for future analytical approaches targeting nitrosamines in similarly challenging pharmaceutical products. 니트로사민 불순물은 유전독성과 발암성 위험이 입증됨에 따라 의약품의 품질 및 규제 적합성 측면에서 중대한 이슈로 부각되었다. 글로벌 규제기관들의 회수 조치 증가와 강화된 관리 감독은, 민감하고 신뢰성 있으며 제형 특이적인 분석법 개발의 시급성을 대두시켰다. 일반 정제 및 캡슐과 같은 고형 경구 제형에 대한 니트로사민 분석법은 많은 진전을 이루었으나, 반고형제 및 서방형 제형과 같은 복합 제형에 대해서는 여전히 분석상의 과제가 존재한다. 본 학위논문은 이러한 미개척 제형에 대한 최적화된 분석법을 개발하고 검증함으로써 니트로사민 불순물 시험법의 현재 수준을 한층 향상시키는 것을 목표로 한다. Part I 에서는 연고, 젤, 크림과 같은 반고형 제형 내 9 종의 니트로사민 불순물 (NDMA, NDEA, NMEA(NEMA), NDPA, NDBA, NPIP, NMOR, DIPNA(NDIPA), EIPNA(NEIPA))을 동시에 정량·정성 분석하기 위한 고감도 GC-MS/MS 분석법을 개발하였다. 반고형 제형은 높은 점도, 복합적인 첨가제 조성, 방향성 휘발성 성분 포함 등으로 인해 시료 전처리 및 크로마토그래피 분리에 어려움을 초래한다. 이를 극복하기 위해 메탄올, 헥산, 물, 디클로로메탄을 활용한 용매 분리법을 적용한 새로운 시료 전처리 방법을 고안하였으며, 60m 길이의 GC 컬럼을 사용하여 피크 중첩 문제를 해결하고 각 분석대상 물질에 적합한 조건을 최적화하였다. 본 분석법은 ICH 가이드라인에 따라 검증되었으며, 특이성, 민감도, 직선성, 정확성, 정밀성 및 검액 안정성 등 모든 항목에서 우수한 성능을 입증하였다. 다양한 시료에서 80% 이상의 회수율이 확보되었으며, 이 방법이 반고형 의약품 및 화장품 제형의 니트로사민 분석에 유효함을 입증하였다. 특히, 현재까지 공인된 공식 분석법이 존재하지 않는 반고형 제형에 대한 분석법으로서 본 연구는 의미 있는 기여를 한다. Part II 는 약동학적 이점과 복약 순응도를 높이기 위해 널리 사용되는 서방형 제형으로 연구를 확장하였다. 이러한 제형은 히드록시프로필메틸셀룰로오스(HPMC), 에틸셀룰로오스, 미결정셀룰로오스 등과 같은 셀룰로오스계 첨가제를 이용해 겔 형성이나 확산 조절을 통해 약물 방출을 제어한다. 그러나 이들 첨가제는 시료 용액의 점도 증가, 미세 섬유 유래 컬럼 막힘 현상 등을 유발하여 HPLC 기반 분석법의 적용에 장애 요인이 될 수 있다. 본 연구에서는 이러한 첨가제를 포함한 서방형 제형에서 니트로사민 불순물을 정확히 분석하기 위해 고려해야 할 주요 유의사항을 제시하였다. 용매 스크리닝 및 스트레스 테스트를 통해 수용성 용매 사용 시 컬럼 막힘 및 피크 테일링이 심화되는 반면, 메탄올을 단독 용매로 사용할 경우 이러한 문제를 효과적으로 완화할 수 있음을 확인하였다. 개량된 분석법은 시타글립틴 제제를 포함한 다양한 서방형 제품에서도 ppb 수준의 니트로사민 불순물을 안정적으로 검출할 수 있었으며, 검증 결과도 모든 기준을 충족하여 실질적인 분석법으로서의 유효성을 확보하였다. 결론적으로 본 연구는 복합 제형에서의 니트로사민 불순물 검출을 위한 종합적인 분석 솔루션을 제공한다. 제형별 특성에 따른 분석 전략 수립의 중요성을 강조하며, 방법 개발 뿐만 아니라 시료 전처리 및 첨가제와의 상호작용 관리 측면에서도 실질적인 통찰을 제시한다. 본 논문에서 확립한 분석법은 반고형 제형과 서방형 제형 모두에 대해 검증된, 적용 가능하고 효율적인 시험 플랫폼으로서 향후 유사 제형의 니트로사민 분석법 개발에 유용한 참조 프레임워크로 활용될 수 있다. 본 연구는 서방성 제제의 미량 불순물 분석 시 적절한 용매 선택의 중요성을 강조하였다. 컬럼 성능에 부정적인 영향을 미치는 요인을 해결함으로써 정확성과 정밀성을 유지하고 분석 효율성을 확보할 수 있으며, 유사한 부형제를 포함하는 제제의 시험법 개발에 유용한 참고자료로 활용될 수 있을 것이다.

CHALLENGES OF SME FINANCING IN GHANA : A CASE OF THE GPSDF

ABANKWA, SAMPSON Graduate School of International Studies Ajou Univ 2017 국내석사

ABSTRACT This study examined the challenges Small and Medium-Scale Enterprises face in accessing funds from financing schemes initiated by the government of Ghana. The study adopted quantitative research approach. The study used questionnaires to collect data from 50 SMEs which participated in the Ghana Private Sector Development Faculty through the Ministry of trade and Industry. Descriptive statistics such as pie chart, bar chart, frequency tables and percentages where used to present the results of the data. The size of establishment affected the SMEs access to fund. Small firms with average low turnover could not receive funding from the scheme because of their inability to meet funding requirements. Locating the office of the GPSDF project was also difficult and time consuming for SMEs which were located outside Accra. It was noted that the banks also shy away from SMEs involved in Agro businesses. Therefore, streamlining these limitations will be integral to the development of the sector. For example, the government of Ghana can offer training and education in SMEs development to both administrators of credit facilities and SMEs operators. Specific financing tools such as venture capital, leasing and factoring can be useful in facilitating greater access to finance. The government can use these schemes to address the precise financing needs and expectations of SMEs which the traditional banks ignore.

Bangladesh’s Garments Industry : a SWOT Analysis and Comparative Study with Vietnam

ALAM, MOHAMMAD KHAIRUL Graduate School of International Studies Ajou Univ 2017 국내석사

Garments industry is considered the life line of the economy and an important area in the development policy of Bangladesh. Bangladesh has set its vision in 2014 to achieve 50 billion US dollar exports earnings from garments sector by 2021.In recent years; global clothing export market has become very competitive. On the other hand, the growth of Bangladesh’s garments sector has been surrounded by a number of difficulties. This study has identified several issues linked to weak infrastructures, low labour productivity, poorly performed compliance, instability in politics as the key challenges to achieve the goal .After analyzing the rapidly growing garments industry of Vietnam, the findings have suggested that only based on low wage rate, cheaper price and better market access facilities, garments sector could not gain expected growth rate. Like Vietnam, Bangladesh’s garments exporters and Governments policy makers should take necessary steps in order to reduce lead time and power crisis, increase labour productivity, and improve compliance standards and political situation.

(THE) ASSESSMENT OF THE IMPACT OF THE EAST AFRICAN COMMUNITY CUSTOMS UNION ON THE INTRA-REGIONAL TRADE

MWAFYELA, NOEL ANDREW Graduate School of International Studies Ajou Univ 2017 국내석사

Abstract Regional trade arrangements have gained high level of popularity among various groups of stakeholders including scholars, business communities and government officials as being an important engine for liberalization of trade and growth. East Africa is not exceptional to this global belief, which as a response to this decided to form an East African Community Customs Union with the aim of liberalizing trade and increasing intra-regional trade. This study analyzes the implementation of EAC-CU since its inception in 2005 and its impact on the intra-regional trade. The analysis based on three phases which are the time when there was no customs union, the time when there was customs union but not fully fledged and the time when there was customs union and was fully fledged. The analysis of intra-regional trade reveals that, since the establishment of the EAC-CU, East African countries have recorded an increase in intra-regional imports, intra-regional exports and intra-regional total trade. However the study further reveals that the region trade more with the rest of the world than how it trade with itself by importing more from the rest of the world (petroleum products, machinery and equipments, intermediate goods for use in further production and finished goods) and exports more to the rest of the world (cotton, tea, coffee, cashew nuts, tobacco, gold, fish products and horticulture products). The study concludes that as the region imports more from the rest of the world, and then it is an opportunity for the EAC companies to improve their production efficiency and start producing some of the products which are currently imported as they are assured of the market. As big percent of the raw materials and intermediate inputs used in the EAC factories are imported from the rest of the world, the study also see this as an opportunity for the region to come up with a regional value chain strategy through identifying raw materials and intermediate goods which can be produced in the region and linking suppliers and buyers of those raw materials and intermediate inputs. The study recommends some measures with the aim of further liberalizing trade and realizing the best in intra-regional trade. Some of these measures include the investment in infrastructure (roads, railways, ports, airways, electricity, water and telecommunication), improvement of technical education through building more and high quality trade schools, improvement of the regional financial market, integration of domestic production chains, awareness creation, development and implementation of regional technology transfer strategy, development and implementation of import substitution strategy, further elimination of NTBs and improvement of security in the region.

THE SIGNIFICANCE OF CULTURE ON BUSINESS NEGOTIATIONS IN THE CONTEXT OF KOREA AND COLOMBIA CASE STUDY OF "EL CAFETAL CO. LTD"

JIMENEZ ROLDAN MAURICIO Graduate School of International Studies Ajou Univ 2016 국내석사

Cross cultural negotiation becomes a common area of research every day because businesses all over the world are spreading their frontiers beyond domestic markets. Effective international negotiators need to know not only the essentials of trade, but also how culture can impact the dealers’ behavior and general negotiation process. Culture strongly influences how people think, communicate, behave and negotiate. If languages mistakes and violations of local protocol are not reduced, probably those differences affect the kinds of transactions, benefits, concessions and future agreements between parties. Korea and Colombia signed a bilateral Free Trade Agreement on 21th February, 2013, but it was declared in effect since 2015. Under this agreement both countries will abolish tariffs on over 96 percent of the other country’s products within ten years after the beginning of this bilateral accord. Korea hopes to increase its exports of automobiles, automotive components, plastics, and steel, while Colombia expects a growth of exports of agricultural products, processed food, textiles and natural resources including crude oil. Successful business between these two countries requires not only a good study of the geographical, economic, and historical situation of its counterpart, but also understanding how cultural differences affect decision making and negotiation process. This research aimed to determine and explain these differences into a descriptive and qualitative way by analyzing a real case of a coffee company dealing cross-cultural negotiations in Seoul as much as some interviews with Korean and Colombian business people involved in diverse international business areas each other, in order to provide practical comments and recommendations for new negotiators who want to explore new markets and trade goods and services because of this FTA. The main issues encountered in this thesis relate to reduce language problems, follow the formal protocol with the appropriate meaning of reputation, familiarization, hierarchy, use of time, and decision-making process. In the same way, strategies to avoid undesirable comments or cultural stereotypes, alternatives to time lag between two countries in terms of feedback and support. Finally, dealing with the most challenging matter when trading Koreans and Colombians, which is to demonstrate how they can be good commercial partners and get very lucrative revenues into a win-win negotiation. Keywords: Culture, Negotiation, Republic of Korea, Republic of Colombia, Coffee Business, FTA.

(THE) IMPACT OF AIR TRANSPORT TO UGANDA’S TRADE VOLUME

MAGUMBA, MOSES BAZIRA Graduate School of International Studies Ajou Univ 2017 국내석사

A lot has been said and speculated about Uganda Airlines since its closure in May 2001. Scholars, businessmen, politicians and many other categories of people have come up with mostly unqualified schools of thought about the role the Airline was playing or would have played to the plight of the country especially towards trade benefits. My quest for some of the answers to ascertain the gravity the airline was/would provide therefore led me to an analysis of a number of literature reviews. This prompted me to examine the effects of some of the determinants of Air transport to Uganda’s trade volume. In my probe, trade volume (TV) which in my case was the summation of total exports to total imports in a given period was the dependent variable while air departures (AD),air exports (AX) and terms of trade (TOT) were taken as the independent variables. I therefore collected data for each of the explanatory variables for the period 1991 to 2014. Unit root test was done to avoid non stationarity otherwise referred to as the trending behavior of variables over time. This was done using the ADF tool and TOT was found to be stationary at level while the other variables were found to be stationary at first difference. The ordinary least squares (OLS) method was used to estimate the relationship between trade volume and its determinants using STATA software. The regression process indicated that air departures and terms of trade have a very small almost insignificant bearing to trade volume. On the other hand, air exports have more gravity to trade volume at 10% level of significance. Finally, a review of the Uganda’s freight charges to the commercial airlines as well as improvement and expansion of the cold storage facilities at the airport would improve the air trade process and consequently the trade volume.

MAJOR SOURCES OF PERSISTENT TRADE DEFICIT IN ETHIOPIA

GUGSA TEMESGEN MULUGETA Graduate School of International Studies Ajou Univ 2016 국내석사

Ethiopia has been experiencing persistent negative trade balance in its economy for a long period. To get the overview of this title, different previous studies were reviewed under literature and the results were found to be mixed in different countries. So, this study was designed to examine major sources of persistent trade deficit in Ethiopian economy. In the analysis, trade balance (TB) which is export value minus import value was chosen as dependent variable and domestic income (GDPD), real exchange rate (ER), an average income of top trading partners (GDPT), money supply (M2) and foreign direct investment (FDI) were chosen as explanatory variables. Data of each variable collected annually over the period 1982 to 2012. To avoid the non-stationarity or trending behavior of variables over time, unit root test was conducted using ADF tool and all variables found to be stationary at their first difference. Ordinary least square (OLS) method was used to estimate the relationship between trade balances and its determinants and analysis were done by using STATA 13 software. The general short run regression results showed that income of domestic residents, trading partner's income and foreign direct investment significant in determining trade balance at 5 percent level of significance. Real exchange rate found to be insignificant while money supply growth significant at 10% level of significance. Finally, income of domestic residents, foreign direct investment (in the short-run) and money supply in the economy were found to be major sources of persistent negative trade balance of Ethiopia.

Transition and integration in Europe : Trade Policies, Implementation of agreement between EU and Ukraine

MOTUZ VIKTORIIA 아주대학교 국제대학원 2016 국내석사

This paper tries to shed some light on possible outcomes of Ukraine’s future integration into European Union (EU), measured by EU Trade Policies. The study is carried to find out the main challenges and possible failures that can impact on trade performance of Ukraine. The main objective of this study is to estimate further development of foreign trade of the country and ease of doing trade related business after integration into EU. The study specifically focuses on analyzing the effect of EU policies on foreign trade. In order to find out the impact of such unification, current research tried to examine possible outcomes, by focusing on three main vectors, these are: “analyses of nowadays Ukraine’s trade performance”, “readiness of Ukraine’s current legislative acts to face such unification”, last but not least, “analyzing the practices of countries who have already joined EU with similar structure of the economy, using example of Bulgaria and Poland”. The primary purpose of this conceptual study was to provide a review of relevant literature about the links between adopting the EU policies and trade performance by applying on the case of Ukraine. The assumed relationship between EU trade policies and trade performance improvement becomes the base of the study. Secondary purpose of this study is to assist policymakers from the Government of Ukraine by providing them with conceptual road map for developing effective policies and tools in enhancing trade related activities and trade growth, through deep analyses of EU policies prior to integration into EU.