• Title/Summary/Keyword: biologics

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Study on Variation of Endemic Mumps Viruses in Korea (한국에서 분리된 유행성이하선염 바이러스 변이에 관한 연구)

  • Min, Kyung-Il;Kim, Do-Keun;Cho, Soo-Yeul;Ahn, Kwang-Soo;Min, Bok-Soon;Kim, Byoung-Guk;Ban, Sang-Ja;Hur, Sook-Jin;Park, Sue-Nie;Lee, Kil-Ung
    • The Journal of Korean Society of Virology
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    • v.30 no.2
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    • pp.113-124
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    • 2000
  • We had isolated 8 viruses from 91 specimen collected at southwest Cheju Province during early spring 1998 and 2 viruses from 9 specimen collected at Chung Nam Province during early spring 1999. To perform cross-reactivity among 4 mumps vaccine strains and 10 wild-type mumps viruse isolates, we immunized mice and took antisera against each virus. There were no antibody titer differences by indirect immunofluorescence assay (IFA), but most isolated mumps viruses showed a little cross-reactivities with Jeryl Lynn and Rubini strains. It has shown similar result by haemagglutination-inhibition (HAI) test. These results show that 4 mumps strains used as vaccine have the protection ability against endemic wild-type mumps viruses. Also the SH gene analysis was performed to identify genotypes. Most isolated mumps viruses belonged to genotype D. These results indicate that endemic mumps viruses in Korea are different to ones isolated in Japan and China.

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The development and validation of a novel liquid chromatography tandem mass spectrometry (LC-MS/MS) procedure for the determination of fluoroquinolones residues in chicken muscle using modified QuEChERS (quick, easy, cheap, effective, rugged and safe) method

  • Park, Sunjin;Kim, Hyobi;Choi, Byungkook;Hong, Chung-Oui;Lee, Seon-Young;Jeon, Inhae;Lee, Su-Young;Kwak, Pilhee;Park, Sung-Won;Kim, Yong-Sang;Lee, Kwang-jick
    • Korean Journal of Veterinary Service
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    • v.42 no.4
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    • pp.289-296
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    • 2019
  • A novel rapid procedure with liquid chromatography tandem mass spectrometry (LC-MS/MS) detection has been developed by changing various conditions including sample preparation such as QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) methodology. This work has been involved the optimization and validation of detection method for fluoroquinolones which are widespread used in livestock especially in the chicken. Five grams of homogenized chicken muscle were extracted with QuEChERS EN and acetonitrile containing 5% formic acid and cleaned with anhydrous magnesium sulfate and C18 sorbent. The separation was performed on Acquity UPLC HSS T3 (2.1 mm×100 mm, 1.8 ㎛) column. The mobile phase A and B were composed of water containing 0.1% formic acid and acetonitrile containing 0.1% formic acid, respectively. Flow rate was 0.25 mL/min and column temperate was 40℃. LC-MS/MS with multiple reaction monitoring has been optimized for ten fluoroquinolones (ciprofloxacin, danofloxacin, difloxacin, enrofloxacin, marbofloxacin, norfloxacin, ofloxacin, orbifloxacin, pefloxacin and sarafloxacin). The method developed in this study has been presented good linearity with correlation coefficient (R2) of 0.9971~0.9998. LOD and LOQ values ranged from 0.09 to 0.76 ppb and from 0.26 to 2.29 ppb, respectively. The average recoveries were from 77.46 to 111.83% at spiked levels of 10.0 and 20.0 ㎍/kg. Relative standard deviation (%) ranged 1.28~11.90% on intra-day and 3.10~8.38 % on inter-day, respectively. This analysis method was applicable to the livestock residue laboratories and was expected to be satisfactory for the residue surveillance system.

Development of Guidance on the Pharmacokinetic Studies of Therapeutic Biologics (생명공학의약품의 약동학 시험 지침 개발 연구)

  • Lee, Hae-Won;Lim, Mi-Sun;Seong, Sook-Jin;Lee, Joo-Mi;Park, Sung-Min;Noh, Keum-Han;Park, Sung-Ho;Kim, Eun-Jung;Kang, Won-Ku;Yoon, Young-Ran
    • Korean Journal of Clinical Pharmacy
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    • v.22 no.1
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    • pp.21-29
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    • 2012
  • Modern biologics are biotechnology-derived therapeutics, including recombinant therapeutic proteins like monoclonal antibodies, cytokines and tissue growth factors. Although the pharmacokinetics of therapeutic biologics should be evaluated based on the same general principles as small molecules, careful considerations should be given to bioanalytics and pharmacokinetics when designing pharmacokinetic studies of biologics during their drug development, due to their different physicochemical properties compared with small molecules. The aim of this study was to develop a draft guidance on pharmacokinetic studies of therapeutic biologics in clinical studies. All the elements outlined in the current Food and Drug Administration (FDA), European Medicinal Agency (EMEA), and International Conference on Harmonisation (ICH) guidelines and regulations, and the related literatures previously published were searched and evaluated. In this draft guidance, the specific problems related to the pharmacokinetics of therapeutic biologics that need special consideration during drug development process were addressed, and differences in pharmacokinetic characteristics between biologics and small molecules affecting the content of the development programme were presented.

Use of Anti-TNF Alpha Blockers Can Reduce Operation Rate and Lead to Growth Gain in Pediatric Crohn's Disease

  • Woo, Min Hyung;Cho, Young Hoon;Sohn, Min Ji;Lee, Eun Joo;Kim, Ju Whi;Moon, Jin Soo;Ko, Jae Sung;Kim, Hyun-young
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.22 no.4
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    • pp.358-368
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    • 2019
  • Purpose: Pediatric Crohn's disease (CD) is directly related to growth and has a high probability of requiring surgical intervention(s); therefore, more active treatment for CD is required for children. This study investigated the impact of biologics on growth and disease course associated with surgery. Methods: This was a retrospective cohort study involving patients diagnosed with CD at the Seoul National University Children's Hospital (Seoul, Korea) between January 2006 and October 2017. The aim was to determine the characteristics of pediatric patients with CD and whether biologics affected growth and the surgical disease course. Results: Among patients who underwent surgery for CD, the mean number of operations per patient was 1.89. The mean time from initial diagnosis to surgery was 19.3 months. The most common procedure was fistulectomy (34%), followed by incision and drainage (25%). In all patients, the use of biologics increased the height (p=0.002) and body mass index (BMI) (p=0.005). Among patients who underwent surgery, height (p=0.004) and BMI (p=0.048) were increased in the group using biologics. Patients who used biologics exhibited a low operation rate only within 2 years after diagnosis, with no differences thereafter (p=0.027). Conclusion: Although biologics could not mitigate the operation rate in pediatric patients who underwent surgery for CD, biological therapy delayed disease progression within 2 years of disease onset. Additionally, biologics conferred growth and BMI benefits in this window period. Therefore, it may be helpful to use biologics for optimal growth in pediatric patients with a high probability of undergoing future surgery.

Determination of cyromazine in commercial insecticides using HPLC-DAD

  • Kim, Young-Wook;Han, Bok Hee;Kang, Young Eun;Rhee, Chae Hong;Seo, Sang-Ji;Kim, Soohee;Jeong, Wooseog;Her, Moon
    • Korean Journal of Veterinary Service
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    • v.43 no.4
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    • pp.261-265
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    • 2020
  • Each commercial cyromazine insecticide has different HPLC conditions. The aim of this study was to establish a standardized chromatographic method for the determination of cyromazine in commercial insecticides. The separation was achieved on two C18 columns - Waters® Bondapak C (4×300 nm i.d., 10 ㎛) and X bridge (4.6×250 nm i.d., 5 ㎛) using a mobile phase composed of water/methanol/ethanolamine (76:24:0.1, v/v), with UV detection at wavelengths 230 nm and 254 nm. A total of six commercial cyromazine insecticides were analyzed. In this study, the optimal high-performance liquid chromatography conditions for the analysis of cyromazine were as follows: a mobile phase of water/methanol/ethanolamine (76:24:0.1, v/v) at a flow rate of 1.0 mL/min and a detection wavelength of 230 nm using a X bridge C18 column (4.6×250 nm i.d., 5 ㎛) at a column temperature of 25℃. The calibration curve was linear in the concentration range of 5~50 ㎍/mL, with a correlation coefficient of 0.99995. The cyromazine detection limit was 0.2 ㎍/mL, and the limit of quantification was 0.59 ㎍/mL. The percentage recovery ranged from 99.8% to 101.0% for cyromazine, and the relative standard deviation was not over 2.0%. The cyromazine concentration ranged from 92.7% to 109.4% and was within the acceptable range (90~120%) for the percent of the labeled amount. This method was found to be suitable for determining cyromazine in commercial insecticides.

Correlations in the results of virus neutralization test, hemagglutination inhibition test, and enzyme-linked immunosorbent assay to determine infectious bronchitis virus vaccine potency

  • Park, Mi-Ja;Joh, Seong-Joon;Choi, Kang-Seuk;Kim, Aeran;Seo, Min-Goo;Song, Jae-Young;Yun, Seon-Jong
    • Korean Journal of Veterinary Research
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    • v.56 no.3
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    • pp.189-192
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    • 2016
  • The virus neutralization (VN) test was used to determine potency of the infectious bronchitis (IB) vaccine. The results of VN, hemagglutination inhibition (HI), and enzyme-linked immunosorbent assay (ELISA) were compared with those of the IBV M41. The $r^2$ values between VN and HI titers and the ELISA antibody titer were 0.8782 and 0.0336, respectively, indicating a high correlation between VN and HI, but not VN and ELISA. The Cohen's kappa coefficient between the VN titer of 2 $log_{10}$ and HI titer of 5 $log_2$ was 0.909. Our results showed that VN could be replaced with HI for testing the potency of IBV M41.

Development of new analytical methods using high performance liquid chromatography for animal hormones; gonadorelin, progesterone, oxytocin and estradiol (고속액체크로마토그래피를 이용한 가축용 호르몬제(고나도렐린, 프로게스테론, 옥시토신, 에스트라디올) 분석방법 개발)

  • Jeong, Kyung Hun;Jeong, Mi Young;Park, Hae-Chul;Hossain, Md Akil;Kim, Dae Gyun;Lee, Kwang-Jick;Kang, Jeong Woo
    • Korean Journal of Veterinary Service
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    • v.40 no.4
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    • pp.253-258
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    • 2017
  • The aim of this study is to develop an optimal analytical method for gonadorelin, progesterone, oxytocin and estradiol, the major components of hormones. A relatively simple and reproducible method using high performance liquid chromatography was developed and as a result of the measurement of specificity, linearity, repeatability, accuracy and intermediated precision, the validity of the developed method was verified with the result of meeting the verification criteria of analytical method validation. Using this newly developed method, 12 post-market veterinary products were tested and the ingredient content were 91.9~116.4%, which satisfied the 90~120% condition of the administrative measure standard. Therefore, if the newly developed method is used for the collection examination of hormone in veterinary medicine, it can be useful as an approved test method.

Evaluation of Haemagglutinin Content by RP-HPLC to Generate Pandemic Influenza Vaccine

  • Kang, Hyunkyung;Roh, Hang Sik;Song, Hyemin;Lee, Kwangmoon;Chung, Seung-Tae;Ban, Sang-ja;Mo, In Pil;An, Beum-Soo;Ahn, Chi-Young
    • Toxicological Research
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    • v.32 no.4
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    • pp.269-274
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    • 2016
  • The potency of influenza vaccine is determined based on its hemagglutinin (HA) content. In general, single radial immunodiffusion (SRID) assay has been utilized as the standard method to measure HA content. However, preparation of reagents for SRID such as antigen and antibody takes approximately 2~3 months, which causes delays in the development of influenza vaccine. Therefore, quantification of HA content by other alternative methods is required. In this study, we measured HA contents of H1N1 antigen and H1N1 influenza vaccine by reverse phase-high performance liquid chromatography (RP-HPLC) methods. The presence of HA1 and HA2 was investigated by silver staining and Western blot assay. In addition, accuracy and repeatability of HA measurement by RP-HPLC were evaluated. Comparison of HA concentration by SRID and RP-HPLC revealed a precise correlation between the two methods. Our results suggest that RP-HPLC assay can replace SRID in the event of a pandemic flu outbreak for rapid vaccine development.

Development of high-performance liquid chromatography methods for the anticoccidials: toltrazuril and diclazuril (고속액체크로마토그래피를 이용한 항원충제 분석법 개발: 톨트라주릴 및 디클라주릴)

  • Jeong, Kyung Hun;Jeong, Miyoung;Park, Hae-Chul;Hossain, Md Akil;Kim, Daegyun;Lee, Kwang-Jick;Kang, Jeong Woo
    • Korean Journal of Veterinary Research
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    • v.57 no.4
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    • pp.223-226
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    • 2017
  • This study was undertaken to develop new analytical methods for assessment of anticoccidials. High-performance liquid chromatography (HPLC) was found to be a fast, reliable, and practical method. The anticoccidials used in this experiment were toltrazuril and diclazuril, and the analysis factors were specificity, linearity, accuracy, repeatability, and intermediate precision. The linearity of each anticoccidial was better than 0.99, and the accuracies were 99.5% and 99.1% with relative SD of 0.5 and 0.4, respectively. To assess whether the developed HPLC method could be effectively applied, toltrazuril and diclazuril post-market veterinary products (five products) that are currently sold were tested. The results revealed no non-compliant items and the method was applied successfully. Therefore, the newly developed HPLC method for anticoccidial assessment described in this study may be useful as a reference method in the Korean Standards of Veterinary Pharmaceuticals for the analysis of toltrazuril and diclazuril.