• 제목/요약/키워드: Pharmaceutical Society of Korea

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Isolation and Identification of Inhibitory Compounds on TNF-$\alpha$ Production from Magnolia fargesii

  • Chae, Sook-Hee;Kim, Pyoung-Su;Cho, Jae-Youl;Park, Ji-Soo;Lee, Jae-Ho;Yoo, Eun-Sook;Baik, Kyong-Up;Lee, Jong-Soo;Park, Myung-Hwan
    • Archives of Pharmacal Research
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    • 제21권1호
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    • pp.67-69
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    • 1998
  • Three TNF-$\alpha$inhibitory lignans were isolated from the flower buds of Magnolia fargesii through bioassay-guided isolation. They were identified as eudesmin, magnolin and lirioresinol-B dimethylether on the basis of their spectroscopic data. All three lignans showed inhibitory effects on TNF-$\alpha$ production in LPS-stimulated murine macrophage cell line, RAW264.7 and eudesmin showed the strongest activity ($IC_{50}=51{\mu}M)$.

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주요국의 의약품 사전상담제도 현황과 정책적 함의 (Consultation Program for Pharmaceutical Development-Lessons from Foreign Countries' Experiences)

  • 박실비아;박은자;한현진
    • 약학회지
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    • 제52권2호
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    • pp.151-159
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    • 2008
  • Consultation program for pharmaceutical development is a new system in which pharmaceutical companies meet and discuss scientific and/or regulatory issues with drug regulatory authority in the research process and before submitting new drug applications. This program helps pharmaceutical companies reduce uncertainties in the research and development and increase the possibilities of getting drug marketing approval. Developed countries such as US, EU, and Japan have implemented various forms of pre-submission meetings or consultation programs since the mid-1990s. The rapid development of technology in pharmaceutical R&D increases the importance of communication between drug development companies and drug regulatory authority in Korea, too. In designing the consultation program, it is desirable to focus on the stages of clinical trials which take the longest period of time and the biggest amount of money in the pharmaceutical R&D process. We suggested that results or recommendations by drug regulatory authorities in pre-submission meetings or consultations be formally documented and considered in review process. Explicit scientific reasons are required for changing the results from consultations.

Recent Trends in the Development of Sustained-Release Dosage Forms

  • Kim, Jung-Ju
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
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    • pp.47-49
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    • 2003
  • Development of drug delivery systems has been recognized as one of portfolios to gain a competitive edge in pharmaceutical industry over 30 years. The application of drug delivery technologies offers pharmaceutical companies and patients several therapeutic benefits, including improving efficacy and adverse effect profiles, enhancing patient compliance and potentially regenerating unsuccessful drugs. (omitted)

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서방성 제제의 생물학적동등성시험을 위한 가이드라인 (Guideline for Bioequivalence Studies of Controlled Release Products)

  • 서현옥;김소희;안미령;안충열;박혜진;오은경;이은주;김보연;김민정;우나리;서희원;정수연
    • Journal of Pharmaceutical Investigation
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    • 제40권1호
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    • pp.63-66
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    • 2010
  • The "Guidance Document for Bioequivalence Study" was revised for adding to bioequivalence studies of controlled-release products after meal(Korea Food & Drug Administration Notification #2008-22, 2008.5.7). The bioequivalence study design for controlled-release products is $2{\times}2$ crossover under fast and fed condition in respect. For studies of controlled-release products under fed study, the same high-fat diet should be taken within 20 minutes in at least a 10-hour fasting state. The drug products should be administered 30 minutes after the meal started. A high-fat(more than 35 percent of total caloric content of the meal) and high-calorie(over 900 calories) meal is recommended as a test meal for fed BE studies.