• Title/Summary/Keyword: Korea GMP

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동물약계

  • 한국동물약품협회
    • 동물약계
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    • no.84
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    • pp.3-5
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    • 2002
  • [ $\cdot$ ]배합사료제조용 동물용의약품등 사용기준 개정(안)에 대한 의견 제출 $\cdot$동물약사감시 행정처분 결과 홍보 $\cdot$구제역 발생 현황 $\cdot$구제역 발생지역 소독약품 무료 지원 $\cdot$구제역 방역용 소독약품 가격 조사 $\cdot$국가검정 동물사 소독에 따른 협조 요청 $\cdot$협회 제3차 이사회 개최 $\cdot$동물약품제조업체 시설개선사업 추진 철저 $\cdot$조합 하반기 알찬거래선 선정 $\cdot$GMP 지정업체 현황 $\cdot$GMP 미지정업체 현황 $\cdot$구제역 소독약품 지원 업체 현황

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Changes in Quality of Shiitake Mushroom(Lentinus edodes) by Different Drying Methods (건조방법에 따른 표고버섯의 품질변화)

  • Baek, Hyung-Hee;Kim, Dong-Man;Kim, Kil-Hwan
    • Korean Journal of Food Science and Technology
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    • v.21 no.1
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    • pp.145-148
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    • 1989
  • Shiitake mushrooms were dried by hot air, far infrared and freeze dryers in order to compare qualities after drying. When hot air drying was performed with the four temperature variations ranged from $45\;to\;70^{\circ}C$, there was tendency to increase volume retention but decrease rehydration ratio, as drying temperature increased. And the largest amout of 5'-GMP was contained in mushroom dried at $50^{\circ}C$. For far infrared drying, volume retentions were lower but rehydration ratios were higher, as compared with hot air drying at the same temperature. In freeze drying, freezing rate had no influence on volume retention but rehydration ratio was highest value when frozen at $-18^{\circ}C$. As shelf temperature increased(drying rate increased), rehydration ratio increased. Also, contents of 5'-AMP, 5'-GMP and 5'-XMP increased with the increase of freezing rate and drying rate.

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A Study on the Application of Risk Management for Medical Device Software Test (의료기기 소프트웨어 테스트 위험관리 적용 방안 연구)

  • Kim, S.H.;Lee, jong-rok;Jeong, Dong-Hun;Park, Hui-Byeong
    • Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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    • 2012.10a
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    • pp.495-497
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    • 2012
  • Development of application risk management for medical device software test. First, Through questionnaires, Medical device manufacturers, Analysis of software validation and risk management status. Second, Analyzed by comparing the difference between black box testing and white box testing. Third, After analyzing the potential for software analysis tools using code derived factors were quantified, Finally, Medical device risk management process so that it can be applied to build the framework by FMEA(Failure Mode and Effect Analysis) technique. Through this Difficult to build software validation and risk management processes for manufacturers to take advantage of support in medical device GMP(Good Manufacture Practice).

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Development and Research into Functional Foods from Hydrolyzed Whey Protein Powder with Sialic Acid as Its Index Component - III. Bacterial Reverse Mutation Testing of Hydrolyzed Whey Protein Powder Containing Normal Concentration of Sialic Acid (7%) with Enzyme Separation Method - (Sialic Acid를 지표성분으로 하는 유청가수분해단백분말의 기능성식품 개발연구 - III. 효소분리로 7% Siailc Acid가 표준적으로 함유된 유청가수분해단백분말의 미생물복귀돌연변이시험 연구 -)

  • Kim, Hee-Kyong;Noh, Hye-Ji;Cho, Hyang-Hyun;Koh, Hong Bum
    • Journal of Dairy Science and Biotechnology
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    • v.34 no.2
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    • pp.137-144
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    • 2016
  • The ultimate research goal of the current study was a development of hydrolyzed whey protein powder (7%-GNANA) manufactured with normal content of sialic acid, a marker compound, that is naturally occurring at 7% concentration in GMP obtained from the milk protein. GMP is a safe food, used worldwide in infant and baby foods, etc. The test substance was prepared using (7% sialic acid containing) GMP as a raw material, and then using alcalase, an enzyme approved as a food additive, after separation of sialic acid with 100% efficiency and 7%-GNANA (containing 7% sialic acid and protein; product name: HELICOBACTROL-7) provided by MEDINUTROL Inc. (Korea). Bacterial reverse mutation (Ames) test was conducted in accordance with GLP Guideline using the test substance specified above. To identify its mutagenic potential against microorganisms, histidine auxotrophic strains of Salmonella Typhimurium, TA98, TA100, TA1535, and TA1537, and tryptophan auxotrophic strain of Escherichia coli, WP2uvrA, were used. The bacterial reverse mutation (Ames) test was performed by dividing the test substances into five different concentration groups (0, 61.7, 185, 556, 1,670, $5,000{\mu}g/plate$). Results of this experiment did not reveal repetitive increase of colony generating values or positive criteria for reverse mutagenicity for any concentration of test substances in any of the five strains, regardless of the presence of a metabolic activation system, and no dose-dependency was identified. In conclusion, the safety of 7%-GNANA test substance was verified by bacterial reverse mutation test conducted before registration of 7%-GNANA as a food additive.

Development and Research on a Functional Hydrolyzed Whey Protein Powder Product with Sialic Acid as a Marker Compound - II. Repeated 90-day Oral Administration Toxicity Test using Rats Administered Whey Protein Powder containing Highly Concentrated Sialic Acid (23%) produced by Enzyme Separation and Solvent Enrichment Method - (Sialic Acid를 지표성분으로 하는 유청가수분해단백분말의 기능성식품 개발연구 - II. 효소분리 용매정제로 고농도 Sialic Acid가 함유된 유청가수분해단백분말(23%)의 랫드를 이용한 90일 반복경구투여 독성시험 평가 연구 -)

  • Noh, Hye-Ji;Cho, Hyang-Hyun;Kim, Hee-Kyong;Koh, Hong-Bum
    • Journal of Dairy Science and Biotechnology
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    • v.34 no.2
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    • pp.117-135
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    • 2016
  • The present study was performed to develop a functional raw food material from hydrolyzed whey protein powder (23%-GNANA) medication containing sialic acid as a marker compound that is naturally occurring at 7% concentration in GMP (glycomacropeptide). GMP is used worldwide in foodstuffs for babies and infants and is obtained from the milk protein as safe food. While the purpose of our detailed evaluation was aimed to assess preliminary NOAEL values for and above 2,000 mg/kg/day, a clinical dose allowance for 23%-GNANA (as per characteristic of a functional health product, a highly refined test substance of 23% (v/v) sialic acid combined in GMP), at the same time we also wanted to assess the safety of GMP hydrolyzate lacking sialic acid but with identical properties as GMP. Animal safety evaluation was conducted using 23%-GNANA as the test substance, produced from hydrolyzed whey protein powder (product name: HELICOBACTROL-23; provided by Medinutrol Inc. [Korea]; composed of 23% sialic acid and GMP protein) after isolating the sialic acid using enzymes approved as food additives, with GMP as a raw material, and subsequently increasing the content of xx up to 23% through 80% (v/v) ethanol soaking and concentrating, in accordance with GLP Guideline. The animal safety evaluation mentioned above was made on the basis of toxicity in SPF Sprague-Dawley female and male rats dosed with 10 mL of the test substance diluted to 0, 1,250, 2,500, and 5,000 mg/kg directly into their stomachs for 90 d. This was determined in terms of the general symptoms and animal viability, weight and amount of feed intake, eye examination, uracrasia tests, hematological and blood biochemical disorder tests, blood coagulation test, abnormal intestine weight, abnormalities during postmortem and histopathological examinations. Statistical significance was set at P<0.05. Based on the toxicity determination, a certain minor effect associated with the test substance was observed in male rats with no major effects of the tested substance, in comparison with the control group dosed with sterilized water. Nevertheless, the NOAEL value, evaluated as per toxicity criteria, was verified as 5,000 mg/kg/day (P<0.05). Similarly, for female rats, a certain minor effect associated with the test substance was observed in 5,000 mg/kg/day dosed group, with no major effect, yet the NOAEL value (as assessed as per toxicity criteria) was determined to be 5,000 mg/kg/day (P<0.05), which was the same as for male rats. Accordingly, the NOAEL values of the test substances for all female and male rats were finally verified as 5,000 mg/kg/day (P<0.05). In conclusion, it was determined that the 23%-GNANA test substance exceeds 2,000 mg/kg/day, the clinical allowance characteristic for functional health food, and was finally evaluated to cause no safety concerns when used as a raw material in functional health food production, which was the ultimate goal of the present study.

The Application of Thera-band on Non-weight Bearing Leg Influence Hip Abductor Activities During Pelvic Drop Exercise in Patients With Gluteus Medius Weakness

  • Su-hwan Cha;Seok-hyun Kim;Seung-min Baik;Heon-seock Cynn
    • Physical Therapy Korea
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    • v.30 no.1
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    • pp.68-77
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    • 2023
  • Background: The weakness of the gluteus medius (GM) is associated with various musculoskeletal disorders. The increasing GM activity without synergistic dominance should be considered when prescribing pelvic drop exercise (PD). Isometric hip extension or flexion of the non-weight bearing leg using thera-band at the ankle during PD may influence hip abductor activities. Objects: To determine how isometric hip extension or flexion of the non-weight bearing leg using thera-band at the ankle during PD influences the activities of three subdivisions of GM (anterior, GMa; middle, GMm; posterior, GMp), tensor fasciae latae (TFL), contralateral quadratus lumborum (QL), and GMp/TFL, GMm/QL activity ratios in patients with GM weakness. Methods: Twenty-three patients with GM weakness were recruited. Three types of PD were performed: PD, PD with an isometric hip extension of the non-weight bearing leg (PDE), and PD with an isometric hip flexion of the non-weight bearing leg (PDF). Surface electromyography (SEMG) was used to measure hip abductor activities. One-way repeated-measures analysis of variance was used to assess the statistical significance of muscle activities and muscle activity ratios. Results: GMa, GMm, and GMp activities were significantly greater during PDF than during PD and PDE (p < 0.001, p = 0.001; p = 0.001, p = 0.005; p = 0.004, p = 0.004; respectively). TFL activity was significantly greater during PDE than during PD and PDF (p < 0.001, p < 0.001, respectively). QL activity was significantly greater during PDF than during PD (p = 0.003). GMp/TFL activity ratio was significantly lower during PDE than during PD and PDF (p = 0.001, p = 0.001, respectively). There were no significant differences in the GMm/QL activity ratio. Conclusion: PDF may be an effective exercise to increase the activities of all three GM subdivisions while minimizing the TFL activity in patients with GM weakness.

Approach to Compositional Effect on Properties of Aspherical Optical Glass for GMP Process with Design of Experiments (실험계획법에 의한 GMP용 비구면 광학유리의 성질에 미치는 조성의 효과 연구)

  • Maeng, Jee-Hun;Kim, Hyeong-Jun;Jung, Ah-Reum;Kim, Jong-Cheol;Choi, Sung-Churl
    • Journal of the Korean Ceramic Society
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    • v.48 no.1
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    • pp.40-45
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    • 2011
  • In this study, the composition of optical glass for GMP(glass molding process) was designed with 'Design of Experiments' method. All the composition batch was performed by 'Create Factorial Design' method. Particularly, $SiO_2$, BaO and $Al_2O_3$ were chosen major parameters for investigating the effects of components on optical and thermal properties. BaO and $Al_2O_3$ strongly influenced on optical and thermal properties, respectively. Finally, the approximate values of desired optical and thermal values were obtained by microtuning of compositions. At the composition of $BaO:Al_2O_3:SiO_2$=10:4:48 (molar ratio), refractive index($n_d$) was 1.5833, coefficient of thermal expansion(CTE) was $104{\times}10^{-7}/^{\circ}C$.