• Title/Summary/Keyword: 생물학적 제제

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Microbial Degradation of Fats and Oils in Industrial Wastewater (유지폐수의 생물학적 처리에 관한 연구)

  • 박춘호;김용기;오평수;유희종
    • Microbiology and Biotechnology Letters
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    • v.19 no.1
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    • pp.88-93
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    • 1991
  • The biodegradable bacteria for fats and oils were isolatcd from soil and wastewater. The isolated strain was designated as LW-27 which had high COD removal rate and biodegr2idability on fats and oils, and was identified as pseudomonas chlrorapihis. The cell viability of LW-27 which produced by vacuum drying at $45^{\circ}C$ for 24 hours was 82%. When the wastewater was mixed with LW-27 agent (0.1g/ day) on the activated sludge unit, the removal rates of COD, BOD and n-hexanc extract of the effluents were about 92.9%, 94.8% and 98.0%, respectively.

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동물약사

  • 한국동물약품협회
    • 동물약계
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    • no.26
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    • pp.2-4
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    • 1995
  • [ $\cdot$ ]생물학적제제 국가검정품 및 보관품 발췌기준

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동물약계

  • 한국동물약품협회
    • 동물약계
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    • no.57
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    • pp.3.2-3.2
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    • 1998
  • [ $\cdot$ ]생물학적제제 약사감시 강화 $\cdot$돼지콜레라 근절을 위한 방역 철저 $\cdot$국제 사료 및 동물약품 박람회 참가자 모집

동물약계

  • 한국동물약품협회
    • 동물약계
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    • no.6
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    • pp.3-3
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    • 1993
  • 1. 대표자 변경 2. 국가검정 동물용의약품 국가검정 면제 3. 허가사항 변경 4. 부정유통 동물약품 조사보고 5. 생물학적제제 부자재 제작업체 선정 6. 동물약품 분류번호 재조정

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Comparison of Enalapril Maleate Tablets on Bioavailability and the Time Course of Inhibition of Plasma Angiotensin-Converting Enzyme (Enalapril Maleate 정제의 동등성에 관한 연구 ; 약동학적 성상 및 혈장 ACE 활성도 억제 효과)

  • Jang, In-Jin;Jang, Byung-Soo;Shin, Sang-Goo;Shin, Jae-Gook;Rho, Il-Kun;Lee, Kyeong-Hun;Park, Chan-Woong
    • The Korean Journal of Pharmacology
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    • v.26 no.2
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    • pp.219-226
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    • 1990
  • Enalapril maleate tablets of two different producers were tested for bioequivalence. Enalapril is rapidly metabolized to an active metabolite, enalaprilat which inhibits angiotensin-converting enzyme (ACE). The pharmacokinetics of enalapril maleate and the time course of inhibition of plasma ACE activity after administration of the drugs were studied. Two single doses of 10mg each of enalapril maleate were administered orally to twelve male volunteers in a balanced, randomized, two-way crossover investigation. Plasma enalaprilat concentrations were determined over a 23-hour after the dose by enzyme inhibition assay and enalapril by the same method following in vitro hydrolysis. Urinary recoveries of enalapril and enalaprilat were determined for the calculation of renal clearance. Plasma ACE activity was determined by an enzyme assay. Peak plasma levels of enalapril were observed about 1 hour after the doses, and practically all enalapril had disappeared from plasma within 6 hour. Peak enalapril concentrations of both formulations were almost identical ($Vasotec^{\circledR}$, 61.38 ng/ml; $Beartec^{\circledR}$, 64.27 ng/ml). The values of the pharmacokinetic parameters of enalaprilat computed for $Vasotec^{\circledR}$ and $Beartec^{\circledR}$ tablets are presented in that order; area under the curve=330.63:320.96 $ng{\cdot}hr/ml$; peak concentration=38.63:39.43 ng/ml; time to peak=3.83:4.08 hour; elimination half-life=3.95:3.92 hours. No statistically significant difference was detected when area under the curve and all other parameters were compared. Using criteria of 95% confidence interval for the comparison of these parameters, only the upper limits of area under the curve and time to peak of enalapril were over 120%. All the parameters of enalaprilat were acceptable. Percent inhibition of plasma ACE to plasma enalaprilat concentration showed the sigmoid concentration-inhibition relationship. Time courses of plasma ACE inhibition after the administration of both formulations were quite similar. The formulations were found to be equivalent when compared on the premise that no significant difference was detected when pharmacokientic parameters and inhibition of ACE activity were compared, based on the confidence limits analysis.

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Some Remarks on Consistency Test of Add-on Test in Bioequivalence Trials (생물학적 동등성 시험에서 추가시험의 일관성 검정에 대한 소고)

  • Ha, Myoung-Ho;Park, Sang-Gue
    • Communications for Statistical Applications and Methods
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    • v.19 no.1
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    • pp.47-55
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    • 2012
  • The newly revised bioequivalence guideline of Korea allows the add-on test since July 1, 2008 when the initial bioequivalence trial fails to show the equivalence of two drugs. The statistical model of the add-on test and its two stage testing procedures are discussed. Some statistical points of consistency test in the add-on test are considered and the issue on the sample size of add-on test is discussed. Some reasonable alternative like Japan's guideline for bioequivalence studies is recommended to secure the proper use of an add-on study through some simulation studies.

동물약계

  • 한국동물약품협회
    • 동물약계
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    • no.100
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    • pp.3-6
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    • 2005
  • [ $\cdot$ ]동물용의약품 관련 법령 개정 수요조사 $\cdot$수출전시회 전략협의회 개최 $\cdot$중소기업 현장체험단 운영 $\cdot$소 부루세라병 방역보완 대책 추진 $\cdot$동물용의약품 산업현황 조사 $\cdot$동물약사감시 행정처분 결과 홍보 $\cdot$통관 단일창구 구축방안 검토 연찬회 참석 $\cdot$제4차 이사회 개최 $\cdot$수출전시회 잔략협의회 개최 $\cdot$제1차 백신제조특별소위원회 개최 $\cdot$제1차 수입백신특별소위원회 개최 $\cdot$동물약품 마케팅 교육 실시 $\cdot$백신제조특별소위원회 실무위원회 개최 $\cdot$생물학적제제 자가 품질검사 관련 건의 $\cdot$법제윤리위원회 개최 $\cdot$제2차 백신제조특별소위원회 개최 $\cdot$동물약품 GMP 실무교육 실시 $\cdot$수입 생물학적제제 국가검정 면제 건의 $\cdot$수출촉진단 회의 개최 $\cdot$조합 2005년도 알선품목 선정 $\cdot$VIV ASIA 2005 전시회 참가 결과 $\cdot$ VIV ASIA 2005 - Daily statistics report

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