• Title/Summary/Keyword: Regulatory change

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Usefulness of SUPAC-SS in Dealing with Postapproval Changes to Semisold Dosage Forms (반고형 제제의 제품허가 후 변경사항을 다루는 SUPAC-SS)

  • Cho, Mi-Hyun;Suk, Kui-Duk;Sah, Hong-Kee
    • Journal of Pharmaceutical Investigation
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    • v.35 no.3
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    • pp.207-224
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    • 2005
  • The objective of this study was to explore the principles of SUPAC-SS and its regulatory application in handling postapproval changes to nonsterile semisolid dosage forms. The types of postapproval changes that SUPAC-SS described were modifications in formulation (components and composition), batch size, manufacturing equipment & process, and the site of manufacturing. SUPAC-SS defined the levels of postapproval changes and what chemistry, manufacturing, and control tests should be conducted for each change level. The guidance also specified several occasions the manufacturers should perform in vitro release test (Franz cell diffusion test) and/or in vivo bioequivalence test. Finally, SUPAC-SS classified appropriate filing forms to be used in supporting postapproval changes. It was crystal clear that SUPAC-SS helped maintain the safety and quality of approved semisolid dosage forms when they were subject to certain postapproval changes. The availability of SUPAC-SS made contributions to reducing regulatory burdens of the industry, as well as expediting the postapproval process of regulatory agencies. This study also shed light on the background of relevant pharmaceutical sciences that the SUPAC-SS guidance adopted. Finally, the KFDA and the industry were strongly urged to implant a similar guidance in handling postapproval changes to semisolid dosage forms available in the Korean marketplace.

Regulation of Gene Expression for Amino Acid Biosynthesis in the Yeast, Sacchromyces cerevisiae

  • Lea, Ho Zoo
    • Proceedings of the Zoological Society Korea Conference
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    • 1995.10b
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    • pp.82-82
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    • 1995
  • Regulation of enzyme synthesis by transcriptional and translational control systems provides rather stable adaptation to change of amino acid level in the growth medium, while manipulation of enzyme activity through endproduct feedback inhibition represents rather short-term and reversible ways of adjusting metabolic fluctuation of amino acid level. Various control mechanisms interplay to regulate genes encoding enzymes for amino acid biosynthesis in the yeast, Sacchromyces cerevisiae. When amino acids are in short supply, genes under a cross-pathway regulatory mechanism Or general amino acid control (general control) increase their action, in which Gcn4p is the major positive regulator of gene expression. When cells are cultured in minimal medium, basal level expression is also regulated by supplementary control elements, where inorganic phosphate level is additionally involved. Most of amino acid biosynthetic genes are also regulated by the level of endproduct of the pathway. This pathway-specific regulatory mechanism is called specific amino acid control (specific controD, under which gene expression is reduced when endproduct is present in the medium. Derepression of a gene through general control can be usually overridden by repression through specific control, where the endproduct level of that particular pathway is high and not limiting. In this presentation, regulatory factors for basal level expression and general control of yeast amino acid biosynthesis will be discussed, m addition to pathway-specific repression patterns and interaction between CrOSS- and specific-control mechanisms. Preliminary results are also presented from the investigation of the cloned genes in the threonine biosynthetic pathway of the yeast. yeast.

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A Study on the Judicial Judgment of Flight Regulations under the Aviation Safety Act (항공안전법상 운항규정의 사법적 판단에 관한 고찰 )

  • Sung-mi Kim;Hee-bok Ahn;Un-jin Yeo;Ho-won Hwang
    • Journal of the Korean Society for Aviation and Aeronautics
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    • v.31 no.3
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    • pp.161-171
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    • 2023
  • The traditional safety management method starts with the misconception that similar accidents will recur if the inappropriate behavior of the person who caused the accident is investigated and punishment is not judged. However, in modern safety management, incidents or situations occur when negative conditions latent in the system are mutually influenced and triggered. The precedent for revoking the disposition of suspension of first officer A of Eastar Jet, which won a legal lawsuit against the administrative regulatory authority, is a representative example that will serve as an opportunity for the administrative regulatory authority to break away from the punishment-oriented safety management method of the past. On the other hand, airmans and air carriers also need to have a clear understanding of flight regulations, and when judicial judgment is required, predictable and effective legal effects can be obtained by preparing clear standards for flight regulations. In addition, administrative regulatory authorities expect a change from the punishment-oriented safety management policy of the past to a systematic safety management policy.

Isolation of a Hypoxia/Reoxygenation Regulatory Factor in Rat Astrocytes (흰쥐 성상세포에서 산소농도의존성 유전자의 분리)

  • Park Jeong-Ae;Song Hyun-Seok;Lee Hye-Shin;Kim Kyu-Won
    • YAKHAK HOEJI
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    • v.50 no.2
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    • pp.124-128
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    • 2006
  • Astrocyte has emerged as an active regulator of brain function, which connects between blood vessels and neurons as well as is a structural component of the blood-brain barrier, From its structural characteristics, astrocyte seems to sensitively respond to oxygen tension, and, in turn, generate diverse cellular cascades. Therefore, to reveal astrocytlc events by oxygen change, we screened genes whose expressions are upregulated under reoxygenation after hypoxic stress using cDNA representational difference analysis (RDA) technique. Meteorin that regulates glial differentiation was isolated from primary cultured rat astrocytes as a hypoxia/reoxygenation regulatory factor. We cloned rat version of Meteorin (rMe-teorin) and determined full-size sequences of rMeteorin. In addition, RT-PCR analysis revealed that Meteorin was increased under reoxygenation in astrocytes and highly expressed in the developing brain. Collectively, these results suggest that Meteorin may regulate astrocyte-mediated effects in response to the change of oxygen tension in the pathophysiological states.

Normative-Legal and Information Security of Socio-Political Processes in Ukraine: a Comparative Aspect

  • Goshovska, Valentyna;Danylenko, Lydiia;Chukhrai, Ihor;Chukhrai, Nataliia;Kononenko, Pavlo
    • International Journal of Computer Science & Network Security
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    • v.22 no.10
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    • pp.57-66
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    • 2022
  • The aim of the article is to investigate socio-political processes in Ukraine on the basis of institutional and behavioral approaches, in particular their regulatory and informational support. Methodology. To determine the nature and content of sociopolitical processes, the following approaches have been used: 1. Institutional approach in order to analyze the development of Ukraine's political institutions. 2. The behavioral approach has been used for the analysis of socio-political processes in Ukraine in the context of political behavior of citizens, their political activity which forms the political culture of the country. Results. The general features of the socio-political situation in Ukraine are as follows: the formed model of government, which can be conditionally described as "presidential"; public demand for new leaders remains at a high level; the society has no common vision of further development; significant tendency of reduction of real incomes of a significant part of the society and strengthening of fiscal pressure on businessmen will get a public response after some time. Increasing levels of voice, accountability, efficiency of governance and the quality of the regulatory environment indicate a slow change in the political system, which will have a positive impact on public sentiment in the future. At the same time, there has been little change in the quality of Ukraine's institutions to ensure political stability, the rule of law and control of corruption. There are no cardinal changes in the development of the institution of property rights, protection of intellectual rights, changes in the sphere of ethics and control of corruption. Thus, Ukraine's political institutions have not been able to bring about any change in the social-political processes. Accordingly, an average level of trust and confidence of citizens in political institutions and negative public sentiment regarding their perception and future change can be traced in Ukraine.

The Regulatory Domain of Troponin C: To Be Flexible or Not To Be Flexible

  • Gagne, Stephane M.;Sykes, Michael T.;Sykes, Brain D.
    • Journal of the Korean Magnetic Resonance Society
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    • v.2 no.2
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    • pp.131-140
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    • 1998
  • The calcium-induced structural changes in the skeletal muscle regulatory protein troponin C (NTnC) involve a transition from a ‘closed’to an ‘open’structure with the concomitant exposure of a large hydrophobic interaction site for target proteins. Structural studies have served to define this conformational change and elucidate the mechanism of the linkage between calcium binding and the induced structural changes. There are now several structures of NTnC available from both NMR and X-ray crystallography. Comparison of the calcium bound structures reveals differences in the level of opening. We have considered the concept of a flexible open state of NTnC as a possible explanation for this apparent discrepancy. We also present simulations of the closed-to-open transition which are in agreement with the flexibility concept and with experimental energetics data.

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Study on Protective Coating Management Status in Overseas Nuclear Power Plant (해외 원자력발전소 방호도장 유지관리 현황 고찰)

  • Lim, Sang-Jun
    • Proceedings of the Korean Institute of Building Construction Conference
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    • 2018.05a
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    • pp.318-319
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    • 2018
  • Protective coatings at nuclear power plants should be designed to withstand exposure to ambient conditions during normal operation or design-basis accidents. However, there was a change in the perception of the protective coating to the revision of the Regulatory Guidelines by the NRC in July 2000. In other words, maintenance guidelines have been strengthened in order to minimize the clogging of the cooling water system due to the substances in the containment building. Therefore, KHNP, the contractor and operator of the nuclear power plant, plans to develop the coating system for nuclear power plants in accordance with the regulation, and plans to develop its own coating expert.

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Measurement of vibration and stress for APR-1400 reactor internals

  • Ko, Do-Young;Kim, Kyu-Hyung
    • Nuclear Engineering and Technology
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    • v.50 no.6
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    • pp.963-970
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    • 2018
  • The U.S. Nuclear Regulatory Commission, Regulatory Guide 1.20 needs to perform a comprehensive vibration assessment program for reactor internals during preoperational and startup testing for nuclear power plants and extended power uprate. Although the measurement program is one of the core programs, it is rarely carried out except for a first-of-a-kind or a unique design. This article describes measurement results of vibration and stress for the comprehensive vibration assessment program for an APR-1400 reactor internals. The measurement was performed at an upper guide structure during the pre-core hot functional test of Shin Kori unit 4 reactor internals because the Shin Kori unit 3 and 4 are the first construction project for the APR-1400, and the upper guide structure assembly was to design change compared with the valid prototype. We confirmed that all measured results are within the test acceptance criteria. It means that the structural integrity of the APR-1400 reactor internals was secured for the flow-induced vibration.