• Title/Summary/Keyword: Good Manufacturing Practice

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Entrepreneurial Ecosystem - What Boosts Herders' Business Most in Mongolia?

  • Delgersaikhan, Amarjargal
    • STI Policy Review
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    • v.8 no.2
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    • pp.94-109
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    • 2017
  • Entrepreneurship is a creation of new combinations of goods and services. Today, every aspect of business operations has been changing, which we call development. The conventional business included production and manufacturing of goods and serving things the customer needed. Today, the business has changed form so that the demands of customers are shaped by the good or service which has been created by the businesses. Entrepreneurship in Mongolia is not a new concept but nowadays the number of entrepreneurs in Mongolia has grown sharply. Mongolia was a nomadic culture during its history and is probably the only nomadic culture left in the world today. Mongolian herders are the largest and the most powerful representation of successful entrepreneurs in Mongolia. Another practice of herders in the world are in Australia. Along with a comparison of the policy and government support system of Australia, this study intends to assess how 6 factors of the entrepreneurial ecosystem fit herders in Mongolia. As a result of this assessment, we propose policy to support the entrepreneurial mechanism of herders and identify cultural factors which support the existence of herding.

Dual Monopolies of New Durables and Their Ancillaries: Exclusive Supply Contracts

  • Flath, David
    • Asian Journal of Innovation and Policy
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    • v.7 no.1
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    • pp.207-234
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    • 2018
  • A manufacturer of a durable good typically purchases supplies, including parts for assembly - that are also useful for repairs - from independent "original equipment suppliers" with which it contracts. The manufacturer is a branded monopolist of its final assembled product. To put into effect also a monopoly of the replacement parts, it must stipulate in its arrangements with independent suppliers of the parts that they not supply such patented parts to any other buyer. Durable good owners would then only be able to obtain their requirements of replacement parts from the same company that supplied the durable. This would amount to a tie-in of replacement parts to the direct purchase of new durables. And that describes the apparently widespread practice of automobile manufacturers in India, as exposed in a recent case before the Competition Commission of India (Samsher Kataria v Honda Siel Cars India Limited and others). Here, I will argue that such tie-in enabled automotive manufacturers to more fully appropriate consumer surplus, which induced them to lower the price of new cars, sell more cars and also sell more repair parts. The tie-in expanded the auto parts industry and promoted new entry. The main restraint on expansion of India's automotive manufacturing is not monopoly. It is government protection in the form of tariffs on automobiles and auto parts.

Effect of Alkali Salts Adding on the Cooking Quality in Dried Noodles (면류용 알칼리제 처리가 건면의 조리특성에 미치는 영향)

  • 문태용;이성갑
    • Journal of the Korean Professional Engineers Association
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    • v.33 no.3
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    • pp.71-79
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    • 2000
  • The effects of alkali salts adding on the cooking quality improving in dried noodles were investigated in the good texture maintaining for preventing solid soluble losses ,through chemical analysis and actual manufacturing practice ,the following results were obtained. Experiments were took a special flour of ASW:DNS=70:30, thickening agent(TA) composed of K2CO3 58%, Na2CO3 36% and Na4P2076%, and emulsified oil(EO) mixing of corn oil 44%, polysorbate 23%, emulsifier(ester of glycerin and fatty acids) 21%, soy lecithin 12%. When the mixing ratio of TA and EO to flour, is 0.03 and 1.5%(w/w) or morel than, satisfied the good quality. The water soluble solid matters content of the lowest 3.2% in the treating group that TA and EO is 0.03 and 1.5%(w/w) respectively, comparing to the 7.3% in the control group provides a excellent cooking quality. The research achieves the similar effects at specific gravity, water absorption ratio, weight increasing rate and volume expansion ratio. According to appearance test the more treating of TA turn the noodle into deeper yellow-green color. Turning to the deeper yellow color according to the increasing of EO provides better

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Development of Process Analytical Technology (PAT) for Total Quality Innovation on Pharmaceutical Processes (의약품 제조공정에서의 전사적 품질혁신을 위한 공정분석기술 개발)

  • Shin, Sang-Mun;Park, Kyung-Jin;Choi, Yong-Sun;Lee, Sang-Kil;Choi, Guang-Jin;Kwon, Byung-Soo;Cho, Byung-Rae
    • Journal of Pharmaceutical Investigation
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    • v.37 no.6
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    • pp.329-338
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    • 2007
  • The quality assurance issue of drug products is more important than the general product because it is highly related to the human health and life. In this reason, the regulatory guide lines have continuously been intensified all around the world. In order to achieve effective quality assurance and real-time product release (RTPR) of drug products, process analytical technology (PAT), which can analyze and control a manufacturing process, has been proposed from the United States. With the PAT process, we can obtain significant process features of materials, quality characteristics and product capabilities from a raw material to the final product in the real-time procedure. PAT can also be utilized to process validation using information system that can analyze the risk of drug products through out an entire product life-cycle. In this paper, we first offered a new concept for the off-line process design methods to prepare the improved quality assurance restrictions and a real-time control method by establishing an information system. We also introduced an automatic inspection system by obtaining surrogate variables based on drug product formulations. Finally, we proposed an advanced PAT concept using validation and feedback principles through out the entire life-cycle of drug product manufacturing processes.

National Strategic Planning For Facilitating the Development of New Drugs in the Korea Food and Drug Administration (국내 신약개발 촉진을 위한 식약청의 국가연구개발 사업 전략수립)

  • Kim, Jong-Wook;Kwon, Kwang-Il;Yoo, Kwang-Soo;Park, So-Hyun;Lim, Chul-Joo;Choi, Don-Woong
    • Journal of the Korean Applied Science and Technology
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    • v.25 no.4
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    • pp.539-555
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    • 2008
  • It is well understood that developing new drugs is one of the highest value-added businesses in a country; however, the current governments' spending in pharmaceutical research and development(R&D) is minimal in Korea. This paper suggests that different governmental bodies should take in charge of different stages of the R&D process in order to maximize the use of limited government research funding. First, during the initial phase of the drug development, including clinical trials, the Ministry of Education, Science and Technology is the most appropriate governmental organization to support the research. For later procedures such as supporting the industries for exporting developed drugs, legislative approvals, and building infrastructure for future clinical trials should be supported by the Ministry of Knowledge and Economy and the Ministry of Health and Welfare along with the Korea Food and Drug Administration(KFDA). The KFDA, which is the main governmental agency approving newly developed drugs in the market, will need to take a crucial responsibility in the initial phase of the pharmaceutical R&D by guiding the industries with timely and proper information. As a first step, it is recommended to set up and operate a center for supporting new drugs, so that the industries can facilitate the development of marketable drugs which meet customers' needs. Later, in order to expedite the process of exporting and getting approvals of the newly developed drugs from foreign countries, it is necessary to develop new approval system, which includes introduction of the Good Manufacturing Practice (GMP), mandatory validation system, and education program for supporting expertise. Lastly, the KFDA needs to take an active role in developing Korean pharmaceutical industries by communicating with other foreign governments with regards to the globalization of the Korean pharmaceutical industries. For example, as a follow up after the Free Trade Agreement(FTA), active discussion on GLP of Mutual Recognition Agreement(MRA) with the United States of America, should be seriously considered.

Quality Control Tests and Acceptance Criteria of Diagnostic Radiopharmaceuticals (진단용 방사성의약품의 품질관리시험 및 기준)

  • Park, Jun Young
    • Korean Journal of Clinical Laboratory Science
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    • v.53 no.1
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    • pp.1-10
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    • 2021
  • Radiopharmaceuticals are drugs that contain radioisotopes and are used in the diagnosis, treatment, or investigation of diseases. Radiopharmaceuticals must be manufactured in compliance with good manufacturing practice regulations and subjected to quality control before they are administered to patients to ensure the safety of the drug. Radiopharmaceuticals for administration to humans need to be sterile and pyrogen-free. Hence, sterility tests and membrane filter integrity tests are carried out to confirm the asepticity of the finished drug product, and a bacterial endotoxin test conducted to assess contamination, if any, by pyrogens. The physical appearance and the absence of foreign insoluble substances should be confirmed by a visual inspection. The chemical purity, residual solvents, and pH should be evaluated because residual by-products and impurities in the finished product can be harmful to patients. The half-life, radiochemical purity, radionuclidic purity, and strength need to be assessed by analyzing the radiation emitted from radiopharmaceuticals to verify that the radioisotope contents are properly labeled on pharmaceuticals. Radiopharmaceuticals always carry the risk of radiation exposure. Therefore, the time taken for quality control tests should be minimized and care should be taken to prevent radiation exposure during handling. This review discusses the quality control procedures and acceptance criteria for a diagnostic radiopharmaceutical.

A Proposal for Research Process of Botanical Drug based Clinical Traditional Korean Medicine - Historical Evidence-Based Medicine II - (한의학임상에 기초를 둔 천연물신약 연구과정에 대한 소고 - 역사적 근거 발굴부터 천연물신약 임상시험계획승인신청까지 -)

  • Eom, Seok-ki;Kim, Se-hyun;Kim, Kyung-suk;Park, Sang-jae;Eo, Wan-kyu;Choi, Won-cheol
    • Journal of Korean Medical classics
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    • v.23 no.4
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    • pp.63-102
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    • 2010
  • Purpose : To propose various types of clinical research which is feasible for botanical new drug (IND) development processes, and suggest essential steps to development of study protocol for IND. Methods : Literature-based discussions and one research group's experience is given regarding domestic act, regulation, and system. Results : In order to get an approval of IND for botanical drug in Korea there are several types of clinical research to conduct. In quality control steps for standardized medicinal herbs, case reports or case series can be conducted, and for good manufacturing practice(GMP) steps, we can conduct case reports, case series, and retrospective cohort studies. In addition, as long as we gathered good laboratory practice(GLP) data we can conduct up to quasi-experimental studies and clinical trials including investigator initiated trials. In order to conduct these studies development of study protocol is essential. First, we obtain historical evidence including target disease and indication, efficacy, safety, and endpoints by reviewing medical classics. Second, we obtain clinically and statistically important data by conducting non-clinical studies, observation studies, and quasi-experimental studies. Third, we generate research hypotheses and purposes and explore methodologies, endpoints, clinical practice guidelines, cost-effectiveness, and commercial potential. Finally, we develop study protocol with aid of biostatistician or expert in contract research organization. Discussions and conclusions : This study have obvious limitations in that most thoughts, suggestions, and proposes are from one research group's experience. Therefore, we hope to see various types of research in this topic and process from other research group as well.

A study on Satisfactory Degree of Dental Laboratory Heads about Dental Technician Who graduated form Junior college in Seoul and Kyoung Gi ("서울, 경기 지역 치과경기소장의 전문대학 치기공과 출신 치기공사에 대한 만족도 조사")

  • Min, Byoung-Kuk
    • Journal of Technologic Dentistry
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    • v.11 no.1
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    • pp.23-34
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    • 1989
  • The great sudenn change of circle of dental laboratory technology brought mary discord between the new growing environmental group and the old group, In order to know the satisfactory degree of dental laboratory heads about all dental College, This Study was conducted for 49 detal technicians who graduated from junior laboratory heads in Seoul and Kyoung Gi area. The results are abtained as follow- 1. By age The degree of Satisfaction of items about all graduate dental technician were "41$\sim$45 age" group 26.53%), "46$\sim$50 age" group 22.45%, "36$\sim$40 age" group 18.36%, "31$\sim$35 age" group 12.24%, "51$\sim$55 age" group and "56$\sim$60 age" group 8.16% 60$\sim$age group 4.08% in order. 2. By Job Career. The Highest degree item out of Satisfaction about all graduated dental dental technician was 21$\sim$25 years group 28.5%, 16$\sim$20 years 20.4%, 11$\sim$15 years group 12.24%, 26$\sim$20%, 6$\sim$10 years group 4.08%, below 5 years group 2.04% in order. 3. By managing term of respondent's dental laboratory. The Satisfactory degree of items about all gradate technician were 7$\sim$10 years group 36.73% over 15 years group 22.45%, 11$\sim$14 years group 20.41%, 3$\sim$6 years group 14.29% below 2 years group 6.12% in order 4. By dental technician number of respondent's dental laboratory. The satisfactory degree intems about man were as follow; 6$\sim$9 persons group is 42.86 % The Satisfactory degree items about woman were one persons group in 34.69% 5. By born place The dental laboratory heads mean of inters about all dental technician were Seoul group 20.64 %, Kyoung Gi 17.20 %, Jen Nam group 14.99 % Chung Nam 9.5%in order 6. The satisfactory degree of items about all graduate dental technician were neither good nor bad group 32.65%, bad 6.12%, By ability of adaptaton, The satisfactory degree items about man were neither good nor bad group 42.86%, bad group 40.82%. The satisfactory degree of items about woman were neither good nor bad group 40.82% bad group 36.73%. 7. By sincerity. The satisfactory degree of items about man dental technician who graduated from Junior College were neither good nor bad group 52.02%, bad group 4.08, The satisfactory degree about woman dental technician graduated from Junior College were neither good nor bad group 42.86%, bad group 6.12%. 8. By ability of basical of items about man were bad group 40.82 %. The satisfactory degree about woman were 46.94%. 9. By cooperation relation ship. The satisfactory degree of items about man were neither good nor bad group 42.86%, bad group 10.20%. The satisfactory degree about woman were neither good nor bad group 42.86%, bad group 10.20 %. 10. By ability of work. The satisfactory degree of items about man were neither good nor bad group 48.98%, bad group 4.08%. The satisfactory degree about woman were neither good nor bad group 42.86%, bad group 6.12 %. 11. By the curriculum of the dental technician. The satisfactory degree of items about man were neither good nor bad group 67.35%, bad group 2.04%, The satisfactory degree about woman were neither good nor bad group 61.22%, bad group 6.12%. 12. By occupational satisfaction. The satisfactory degree of items about all graduate dental technician were fatisfied group 14.29%. By the out look of employment. The satisfactory degree of items about man greduate dental technician were neither good nor bad group 34.69 %, bad group 10.20%, about woman graduate dental technician were neither good nor bad group 44.90%, bad group 10.20%, Their employment prospect is not so bright or oprimistic due to the glut supply by graduates in the job-seeking market 13. The satisfactory rate on the artificial dental manufacturing world in terms of effects produced by juror College graduate dental technicians shared good group 40.82% bad group 2.04% 14. By cognition of the number of graduate dental technician. The satisfactory degree of dental laboratory heads about man graduate dental technician were too many group 38.78%, few group 6.12% about woman graduated dental technician were neither good nor bad group 30.6% few group 10,20%, The employment opportunities for the artifical dental technicians are getting decreased because of their excessive cumber in supply 15. The opinion regarding the initial salary. ranging from \160,000 to \200,000 for the junior college graduate dental technicians shared 57.14%. The top ratio, while the satisfaction reate on the academic study period of "3-year" group shared 22%, also the top ratio. 16. The improvement policy and prblematic issues presonted by the owner and operatore of atriticial dental manufacturing plants are as shown below First; The viewpoint that they contribute to the improvement of people's oral health in terms of their mission as artificial dental technicians. Second: The cultivation of basic technical ability to cope with clinical practice upon graduation Third; They require guidance in study and research in their filed of profession, that tray may beable to estaclish a from theory.

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Systematic Review of Clinical Research on Daegunjoong-tang for Improvement of Gastrointestinal Motility after Surgery for Gastrointestinal Cancer (소화기암 수술 후 위장관 운동성 개선을 위한 대건중탕의 효과에 대한 임상연구의 체계적 문헌고찰)

  • Han, Ga-jin;Seong, Sin;Kim, Sung-su
    • The Journal of Internal Korean Medicine
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    • v.38 no.6
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    • pp.980-999
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    • 2017
  • Objectives: This study aimed to evaluate the efficacy of Daegunjoong-tang for improvement of gastrointestinal motility after surgery due to gastrointestinal cancer by analyzing the existing clinical research. Methods: Clinical studies about Daegunjoong-tang for improvement of gastrointestinal motility after surgery due to gastrointestinal cancer were identified in a literature search using the search term "Daikenchuto AND cancer AND ileus." The studies were analyzed in terms of design, inclusion and exclusion of participants, intervention, control, outcomes, and results. Results: Nine articles were identified in the literature search. Four trials included colon cancer participants with colectomy, and three studies included gastric cancer with total gastrectomy. The intervention in each case was Daegunjoong-tang, and most interventions were made by a pharmaceutical company with a Good Manufacturing Practice facility. The most frequently used control was a placebo. The methods were diverse, including measuring gastrointestinal function, motility, quality of life, symptom scores with a numeric rating scale, and blood tests. Safety was investigated by recording adverse events. Conclusions: Some issues were discovered by reviewing the existing clinical research about Daegunjoong-tang for improvement of gastrointestinal motility after surgery for gastrointestinal cancer. These results will be utilized as evidence for using Daegunjoong-tang in clinical practice and designing a clinical trial for Korean patients.

Analysis of the Structure and Stability of Erythropoietin by pH and Temperature Changes using Various LC/MS

  • Chang, Seong-Hun;Kim, Hyun-Jung;Kim, Chan-Wha
    • Bulletin of the Korean Chemical Society
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    • v.34 no.9
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    • pp.2663-2670
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    • 2013
  • The purpose of stability testing is to provide evidence about how the quality of a drug varies with time under the influence of a variety of environmental factors. In this study, erythropoietin (EPO) was analyzed under different pH (pH 3 and pH 9) and temperature ($25^{\circ}C$ and $40^{\circ}C$) conditions according to current Good Manufacturing Practice (cGMP) and International Conference on Harmonisation (ICH) guidelines. The molecular weight difference between intact EPO and deglycosylated EPO was determined by SDS-PAGE, and aggregated forms of EPO under thermal stress and high-pH conditions were investigated by size exclusion chromatography. High pH and high temperature induced increases in dimer and high molecular weight aggregate forms of EPO. UPLC-ESI-TOF-MS was applied to analyze the changed modification sites on EPO. Further, normal-phase high-performance liquid chromatography was performed to identify proposed glycan structures and high pH anion exchange chromatography was carried out to investigate any change in carbohydrate composition. The results demonstrated that there were no changes in modification sites or the glycan structure under severe conditions; however, the number of dimers and aggregates increased at $40^{\circ}C$ and pH 9, respectively.