• Clinical and Experimental Vaccine Research
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• v.12 no.3
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• pp.193-208
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• 2023

One of the most significant medical advancements in human history is the development of vaccines. Progress in vaccine development has always been greatly influenced by scientific human innovation. The main objective of vaccine development would be to acquire sufficient evidence of vaccine effectiveness, immunogenicity, safety, and/or quality to support requests for marketing approval. Vaccines are biological products that enhance the body's defenses against infectious diseases. From the first smallpox vaccine to the latest notable coronavirus disease 2019 nasal vaccine, India has come a long way. The development of numerous vaccines, driven by scientific innovation and advancement, combined with researcher's knowledge, has helped to reduce the global burden of disease and mortality rates. The Drugs and Cosmetics Rules of 1945 and the New Drugs and Clinical Trials Rules of 2019 specify the requirements and guidelines for CMC (chemistry, manufacturing, and controls) for all manufactured and imported vaccines, including those against coronavirus infections. This article provides an overview of the regulation pertaining to the development process, registration, and approval procedures for vaccines, particularly in India, along with their brief history.

• Asia-Pacific Journal of Business Venturing and Entrepreneurship
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• v.19 no.3
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• pp.41-51
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• 2024

This study aimed to analyze the effects of ESG management activities of auto parts manufacturers on organizational trust, organizational immersion, and job satisfaction, and to examine the intermediate effects of organizational trust and organizational immersion between ESG management activities and job satisfaction. Research models and hypotheses were established by referring to the theoretical background and empirical analysis of the preceding studies, and 221 questionnaires were secured for members of Busan and Gyeongnam-based auto parts manufacturers C, E, G, and S for empirical analysis. The results of the study are as follows. First, energy saving, regional cluster construction, and compliance ethics management were statistically significant in identifying the relationship between ESG management activities and organizational trust. Second, in the analysis of the impact of ESG management activities on organizational immersion, compliance ethics management showed significant results (+). Third, the analysis of the relationship between organizational trust and job satisfaction showed a significant result of affection (+). Fourth, organizational immersion has been analyzed to have an effect on Jung (+) that is significant for job satisfaction. Finally, the analysis of the parameters of organizational trust and organizational immersion showed that both variables had a medium effect. In conclusion, it was an opportunity for auto parts makers to recognize that they can increase their members' job satisfaction by making efforts to increase trust and immersion in the organization through ESG activities.

• Journal of Pharmacopuncture
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• v.18 no.4
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• pp.38-44
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• 2015

Objectives: Radix Ginseng has been used for thousands of years to treat a wide variety of diseases. Radix ginseng has also been used as a traditional medicine for boosting Qi energy and tonifying the spleen and lungs. Traditionally, its effect could be obtained orally. Nowadays, a new method, the injection of herbal medicine, is being used. This study was performed to investigate the single-dose intravenous toxicity of water-soluble ginseng pharmacopuncture (WSGP) in Sprague-Dawley (SD) rats. Methods: All experiments were carried out at Biotoxtech, an institute authorized to perform non-clinical studies under the regulation of Good Laboratory Practice (GLP). At the age of six weeks, 40 SD rats, 20 male rats and 20 female rats, were allocated into one of 4 groups according to the dosages they would receive. The WSGP was prepared in the Korean Pharmacopuncture Institute under the regulation of Korea-Good Manufacturing Practice (K-GMP). Dosages of WSGP were 0.1, 0.5 and 1.0 mL/animal for the experimental groups, and normal saline was administered to the control group. The rat's general conditions and body weights, the results of their hematological and biochemistry tests, and their necropsy and histopathological findings were investigated to identify the toxicological effect of WSGP injected intravenously. The effect was examined for 14 days after the WSGP injection. This study was performed under the approval of the Institutional Animal Ethics Committee of Biotoxtech. Results: No deaths were found in this single-dose toxicity test on the intravenous injection of WSGP, and no significant changes in the rat's general conditions and body weights, the results on their hematological and biochemistry test, and their necropsy findings were observed during the test. The local area of the injection site showed minial change. The lethal dose was assumed to be over 1.0 mL/animal in both sexes. Conclusion: These results indicate that WSGP is safe at dosages up to 1 mL/animal.

• Journal of Korea Society of Industrial Information Systems
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• v.13 no.4
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• pp.83-97
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• 2008

Recently, as managing organization's stakeholders become important, a viewpoint of corporate social responsibility (CSR) has been changed. Unlike in the past, organizations have performed CSR in their active and strategic point of view. Previous studies about the effect of social responsibility generally focused on customer response, social performance, and financial performance, and studies about the influence on business processes and organizational members are relatively not sufficient. In particular, there is few studies about the relationship among CSR, organization's innovation capability, and non-financial performance. The purpose of this study is to examine the effect of CSR to knowledge management and organizational performance by using multiple regression analysis. Specifically, from the empirical result of this study with 256 Korean finns in diverse industries including the manufacturing, we identified that CSR has positive influence on knowledge management and organizational performance.

• Journal of Pharmacopuncture
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• v.18 no.2
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• pp.76-85
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• 2015

Objectives: Radix Ginseng has been traditionally used as an adaptogen that acts on the adrenal cortex and stimulates or relaxes the nervous system to restore emotional and physical balance and to improve well-being in cases of degenerative disease and/or old age. Radix Ginseng has been used for a long time, but the safety of ginseng pharmacopuncture needs testing. This study was done to analyze the single-dose toxicity of water- soluble ginseng pharmacopuncture (GP) intramuscular injections in rats. Methods: All experiments were performed at Biotoxtech, an institution authorized to perform non clinical studies under the regulations of Good Laboratory Practice (GLP). Each group contained 10 Sprague-Dawley rats, 5 males and 5 females. GP was prepared in a sterile room at the Korean Pharmacopuncture Institute under regulations of Good Manufacturing Practice (GMP). GP dosages were 0.1, 0.5 and 1.0 mL for the experimental groups; normal saline was administered to the control group. The animals general condition was examined daily for 14 days, and the rats were weighed on the starting day and at 3, 7 and 14 days after administration of the pharmacopuncture. Hematological and biochemistry tests and autopsies were done to test the toxicological effect of GP after 14 days. This study was performed with approval from the Institutional Animal Ethics Committee of Biotextech. Results: No deaths were found in this single-dose toxicity test of intramuscular injections of GP, and no significant changes in the general conditions, body weights, hematological and biochemistry tests, and autopsies were observed. The local injection site showed no changes. Based on these results, the lethal dose was assumed to be over 1.0 mL/animal in both sexes. Conclusion: These results suggest that GP is relatively safe. Further studies, including a repeated toxicity test, are needed to provide more concrete evidence for the safety of GP.

• Journal of Pharmacopuncture
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• v.18 no.2
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• pp.67-75
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• 2015

Objectives: This study was carried out to analyze the single-dose toxicity of ShinYangHur (SYH) herbal acupuncture injected into the muscles of Sprague-Dawley (SD) rats. Methods: The SYH herbal acupuncture was made in a clean room at the Korean Pharmacopuncture Institute (KPI, Korea-Good Manufacturing Practice, K-GMP). After the mixing process with sterile distilled water, the pH was controlled to between 7.0 and 7.5. Then, NaCl was added to make a 0.9% isotonic solution by using sterilized equipment. All experiments were conducted at Biotoxtech, an institution authorized to perform non clinical studies under the regulations of Good Laboratory Practice (GLP). SD rats were chosen for the pilot study. Doses of SYH herbal acupuncture, 0.25, 0.5, and 1.0 mL, were administered to the experimental groups, and a dose of normal saline solution, 1.0 mL, was administered to the control group. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results: No deaths or abnormalities occurred in any of the four groups. No significant changes in weight, hematological parameters or clinical chemistry between the control group and the experimental groups were observed. To check for abnormalities in organs and tissues, we used microscopy was used to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs or tissues. Conclusion: The above outcomes suggest that treatment with SYH herbal acupuncture is relatively safe. Further studies on this subject are needed to yield more concrete evidence.

• Journal of Engineering Education Research
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• v.11 no.4
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• pp.11-18
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• 2008

Companies have been making considerable efforts to develop innovative products for better competitiveness in the market, however, the education curriculum for innovative product development (IPD) in domestic universities needs has not been well developed. The present study was intended to identify the needs of students and practitioners regarding teaching subjects, pedagogical methods, and industry-academia collaboration that can be reflected in the development of IPD education curriculum. Through a literature survey 46 IPD teaching subjects of 7 categories (planning, feasibility analysis, concept development, product design, manufacturing process design, production, and ethics & law) were selected. Opinions on the preferences and importances of the teaching subjects, pedagogical methods, and industry-academia collaboration were collected from 53 college students who took courses of product development and 36 practitioners working in product development. While the students preferred the balanced teaching of all the subject categories, the practitioners suggested planning and concept development be taught with high importance; 6 subjects (product development strategy, customer needs identification, market research, concept generation method, design ideation method, and ergonomic design) received high ratings of preference and importance. The students preferred the mix of various pedagogical methods (lecture, discussion, presentation, practice, and case study) and provided needs on each pedagogical method. Lastly, the students wanted an opportunity of learning through industry-academia collaboration and the practitioners provided ideas for mutual benefits between industry and academia. The needs of students and practitioners identified in the study can be effectively applied to develop a better IPD education curriculum.