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Relevant bibliographies by topics / Regulatory basis

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Academic literature on the topic 'Regulatory basis'

Author: Grafiati

Published: 3 June 2025

Last updated: 31 July 2025

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Journal articles on the topic "Regulatory basis"

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Gao, Rong, Sophie Bouillet, and Ann M. Stock. "Structural Basis of Response Regulator Function." Annual Review of Microbiology 73, no. 1 (2019): 175–97. http://dx.doi.org/10.1146/annurev-micro-020518-115931.

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Response regulators function as the output components of two-component systems, which couple the sensing of environmental stimuli to adaptive responses. Response regulators typically contain conserved receiver (REC) domains that function as phosphorylation-regulated switches to control the activities of effector domains that elicit output responses. This modular design is extremely versatile, enabling different regulatory strategies tuned to the needs of individual signaling systems. This review summarizes structural features that underlie response regulator function. An abundance of atomic re

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He, Xiaoyuan, and Shuishu Wang. "Structural basis of DNA sequence recognition by the response regulator PhoP." Acta Crystallographica Section A Foundations and Advances 70, a1 (2014): C1409. http://dx.doi.org/10.1107/s2053273314085908.

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The PhoP-PhoR two-component system plays a key role in regulating virulence of Mycobacterium tuberculosis. The response regulator PhoP is a transcription regulator, and it regulates expression of more than 100 genes. PhoP belongs to the OmpR/PhoB subfamily of response regulators. Despite extensive research in recent years, the molecular mechanism of DNA sequence recognition by this large subfamily of response regulators is not fully understood, especially the role of the N-terminal regulatory domain on DNA binding of the effector domain. Here we present a crystal structure of the full-length P

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Sein-Echaluce, Violeta C., María Carmen Pallarés, Anabel Lostao, et al. "Molecular basis for the integration of environmental signals by FurB from Anabaena sp. PCC 7120." Biochemical Journal 475, no. 1 (2018): 151–68. http://dx.doi.org/10.1042/bcj20170692.

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FUR (Ferric uptake regulator) proteins are among the most important families of transcriptional regulators in prokaryotes, often behaving as global regulators. In the cyanobacterium Anabaena PCC 7120, FurB (Zur, Zinc uptake regulator) controls zinc and redox homeostasis through the repression of target genes in a zinc-dependent manner. In vitro, non-specific binding of FurB to DNA elicits protection against oxidative damage and avoids cleavage by deoxyribonuclease I. The present study provides, for the first time, evidence of the influence of redox environment in the interaction of FurB with r

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Moon, Seongin, Seok-Jun Seo, Won-Myung Chong, Gil-Sung You, Jeong-Hoe Ku, and Ho-Dong Kim. "ICONE23-1111 REGULATORY REQUIREMENTS FOR PYROPROCESSING FACILITY SAFETY BASIS." Proceedings of the International Conference on Nuclear Engineering (ICONE) 2015.23 (2015): _ICONE23–1—_ICONE23–1. http://dx.doi.org/10.1299/jsmeicone.2015.23._icone23-1_60.

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Bereslavska, Olena, and Yana Pіdsosonna. "INSTITUTIONAL BASIS OF CRYPTOASSETS’ REGULATION." Scientific Notes of Ostroh Academy National University, "Economics" Series 1, no. 32(60) (2024): 62–68. http://dx.doi.org/10.25264/2311-5149-2024-32(60)-62-68.

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The article delves into the institutional underpinnings of cryptoasset regulation, asserting that institutional relations and connections among entities extend beyond formal and informal norms and rules. These are complemented by the formation of relevant institutions and organizational relations between them, thereby shaping the institutional environment. This environment consists of the legislative and regulatory framework and the socio-economic mechanisms for regulation, all aimed at achieving collective benefits. The proposal is to view the institutional and economic relations in cryptoass

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Liu, Fenmei, Zihui Su, Peng Chen, et al. "Structural basis for zinc-induced activation of a zinc uptake transcriptional regulator." Nucleic Acids Research 49, no. 11 (2021): 6511–28. http://dx.doi.org/10.1093/nar/gkab432.

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Abstract The zinc uptake regulator (Zur) is a member of the Fur (ferric uptake regulator) family transcriptional regulators that plays important roles in zinc homeostasis and virulence of bacteria. Upon zinc perception, Zur binds to the promoters of zinc responsive genes and controls their transcription. However, the mechanism underlying zinc-mediated Zur activation remains unclear. Here we report a 2.2-Å crystal structure of apo Zur from the phytopathogen Xanthomonas campestris pv. campestris (XcZur), which reveals the molecular mechanism that XcZur exists in a closed inactive state before re

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Gribaldo, Laura. "Haematotoxicology: Scientific Basis and Regulatory Aspects." Alternatives to Laboratory Animals 30, no. 2_suppl (2002): 111–13. http://dx.doi.org/10.1177/026119290203002s17.

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Haematopoietic tissues are the targets of numerous xenobiotics. The purpose of in vitro haematotoxicology is the prediction of adverse haematological effects from toxicants on human haematopoietic targets under controlled experimental conditions in the laboratory. Building on its foundations in experimental haematology and the wealth of haematotoxicological data found in experimental oncology, this field of alternatives toxicology has developed rapidly during the past decade. Preclinical and clinical drug development for anti-cancer drugs differs from that for other pharmaceuticals, because of

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ØYEHAUG, LEIV, ERIK PLAHTE, DAG I. VÅGE, and STIG W. OMHOLT. "The Regulatory Basis of Melanogenic Switching." Journal of Theoretical Biology 215, no. 4 (2002): 449–68. http://dx.doi.org/10.1006/jtbi.2001.2521.

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Viatkin, Konstantyn. "REGULATORY AND LEGAL BASIS OF TERRITORIAL DEVELOPMENT." Urban development and spatial planning, no. 72 (February 21, 2020): 30–40. http://dx.doi.org/10.32347/2076-815x.2020.72.30-40.

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Xu, Q., A. M. Deacon, and I. A. Wilson. "Structural basis of regulatory inactivation of DnaA." Acta Crystallographica Section A Foundations of Crystallography 64, a1 (2008): C334. http://dx.doi.org/10.1107/s0108767308089320.

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Dissertations / Theses on the topic "Regulatory basis"

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Lee, Ji Hyun. "A Regulatory Approach for Extending the Licensing Basis to Include Beyond Design Basis Events." The Ohio State University, 2013. http://rave.ohiolink.edu/etdc/view?acc_num=osu1370937698.

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Wilson, Stephen Stewart 1970. "Antigenic, genetic, and regulatory basis of autoimmune diabetes mellitus in vitro and in vivo." Diss., The University of Arizona, 1997. http://hdl.handle.net/10150/282436.

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This work introduces and explores a novel model which incorporates Fetal Thymus Organ Culture (FTOC) from non-obese Diabetic (NOD) mice to replicate thymic development and function of diabetogenic T cells in vitro. NOD FTOC is shown to posses a predictable diabetogenic activity measured in vitro, and a protective, regulatory activity when adoptively transferred to genetically IDDM-predisposed NOD mice. This in vitro IDDM (ivIDDM) activity is unique to NOD FTOC, and can be abbrogated by co-culture of developing NOD FTOC with FT from immunologically incompetent C.B-17 scid/scid mice. Additionall

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吳達方 and Tat-fong Ng. "Molecular basis for regeneration of CNS: a possible regulatory role of growth associated protein-43." Thesis, The University of Hong Kong (Pokfulam, Hong Kong), 1995. http://hub.hku.hk/bib/B31235219.

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Ng, Tat-fong. "Molecular basis for regeneration of CNS : a possible regulatory role of growth associated protein-43 /." Hong Kong : University of Hong Kong, 1995. http://sunzi.lib.hku.hk/hkuto/record.jsp?B17538786.

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Finley, Matthew James. "Molecular Basis for Kappa-Opioid Regulation of Chemokine Receptor Function." Diss., Temple University Libraries, 2009. http://cdm16002.contentdm.oclc.org/cdm/ref/collection/p245801coll10/id/62878.

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Molecular Biology and Genetics<br>Ph.D.<br>Opioid receptor-mediated regulation of chemokine receptors is vital for the host immune response, development, and neurological function. Previous studies have demonstrated that the kappa opioid receptor (KOR) activation results in decreased infectivity of human immunodeficiency virus 1 (HIV-1) in human peripheral blood mononuclear cells (PBMCs). We have found this effect is due to down-regulation of the major HIV-1 co-receptors, CCR5 and CXCR4. Using molecular techniques, CCR5 and CXCR4 mRNA levels drop dramatically following KOR activation. To disse

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Rivarola, Sena Ana Clarizza. "The molecular basis of carpel evolution." Thesis, Lyon, 2020. http://www.theses.fr/2020LYSEN062.

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Le carpelle est l’organe reproducteur femelle des plantes à fleurs. Nous présentons une analyse transcriptomique comparative, focalisant particulièrement sur le développement des tissus femelles reproducteurs, entre la plante modèle établie Arabidopsis thaliana et la soeur probable du restant des plantes à fleurs vivantes Amborella trichopoda. Des modules de co-expression de gènes ont été d’abord définis et ensuite comparés statistiquement entre espèces sur la base de relations d’orthologie entre tous les gènes dans les deux génomes sous comparaison. Cette étude a révélé des modules génétiques

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Velázquez, Sánchez Diego. "Exploring the regulatory mechanisms of the S. cerevisiae Ppz1 protein phosphatase and the molecular basis for its toxicity." Doctoral thesis, Universitat Autònoma de Barcelona, 2019. http://hdl.handle.net/10803/667958.

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Uno de los más notables componentes en la homeostasis de cationes en levaduras es la proteína fosfatasa Ppz1. El papel de Ppz1 es doble: inhibe la entrada de potasio mediante el control de la actividad de los transportadores Trk1 y Trk2 y atenúa la expresión del gen de la Na+-ATPasa ENA1. Ppz1, está controlada negativamente por dos subunidades reguladoras estructuralmente relacionadas, Hal3 y Vhs3, siendo la primera la más relevante funcionalmente. A parte de esto se ha demostrado que niveles altos de Ppz1 son extremadamente perjudiciales para la célula. El primer objetivo de este trabajo ha

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Su, Ting [Verfasser], and Roland [Akademischer Betreuer] Beckmann. "Structural basis of regulatory ribosome arrest by VemP and rescue of aberrant translational stalling by Vms1 / Ting Su ; Betreuer: Roland Beckmann." München : Universitätsbibliothek der Ludwig-Maximilians-Universität, 2021. http://d-nb.info/1232645478/34.

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Soh, Ying Qi Shirleen. "The genomic and genetic basis of mammalian sexual reproduction : sequence of the mouse Y chromosome, and a gene regulatory program for meiotic prophase." Thesis, Massachusetts Institute of Technology, 2015. http://hdl.handle.net/1721.1/98632.

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Thesis: Ph. D., Massachusetts Institute of Technology, Department of Biology, 2015.<br>Cataloged from PDF version of thesis.<br>Includes bibliographical references.<br>Mammalian sexual reproduction requires sexual determination, sexual differentiation, and the production of haploid gametes. In this thesis, I examined the genomic evolution of the mouse Y chromosome, which instructs sexual determination, and genetic regulation of a program of gene expression for meiosis, a specialized cell cycle which gives rise to haploid gametes. Chapter 2 describes the study of the mouse Y chromosome. Contrar

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Höppner, Malte. "Kapitaladäquanz und Kapitalallokation im Kompositversicherungsunternehmen auf Basis eines „internen Modells“ vor dem Hintergrund aufsichtsrechtlicher Anforderungen und interner Steuerungszwecke." Doctoral thesis, Universitätsbibliothek Leipzig, 2011. http://nbn-resolving.de/urn:nbn:de:bsz:15-qucosa-69889.

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Die vorliegende Arbeit untersucht die neuen Kapitalanforderungen im Rahmen von Solvency II. Zunächst werden dazu die aktuellen aufsichtsrechtlichen Anforderungen diskutiert. Hieraus leitet sich die Notwendigkeit der Überarbeitung der Solvabilitätsanforderungen ab. Die künftigen aufsichtsrechtlichen Anforderungen werden hinsichtlich des Aufgreifens der Problemstellen der bisherigen Solvabilitätsanforderungen erörtert. Der Schwerpunkt liegt auf der Behandlung der Ermittlung der Kapitalanforderung mittels eines internen Modells. Hierfür wird auf Basis eines Beispiel-Versicherungsunternehmen, der

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Books on the topic "Regulatory basis"

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American Chemical Society. Issues in peer review of the scientific basis for regulatory decisions. American Chemical Society, 1985.

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David, Savage, ed. The Scientific and regulatory basis for the geological disposal of radioactive waste. John Wiley, 1995.

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Peterson, L. The technical basis for the NRC's guidelines for external risk communication. Division of Systems Analysis and Regulatory Effectiveness, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, 2004.

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Barbara, Steinhoff, and Blasius Helga, eds. Herbal medicinal products: Scientific and regulatory basis for development, quality assurance and marketing authorisation. Medpharm Scientific Publishers, 2003.

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Switzenbaum, Michael S. Defining biosolids stability: A basis for public and regulatory acceptance ; project 94-REM-1. Water Environment Research Foundation, 1997.

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Tan, Dazhi. Molecular Basis for the Recognition of the Regulatory Stem-loop Structures in Eukaryotic Messenger RNAs. [publisher not identified], 2014.

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Throm, E. D. Regulatory analysis for the resolution of generic issue 82, "beyond design basis accidents in spent fuel pools". Division of Safety Issue Resolution, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, 1989.

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U.S. Nuclear Regulatory Commission. Office of Nuclear Regulatory Research., ed. Draft regulatory guide DG-1081: Alternative radiological source terms for evaluating design basis accidents at nuclear power reactors. U.S. Nuclear Regulatory Commission, Office of Nuclear Regulatory Research, 1999.

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1947-, Martin James Lenial, and American Society of Civil Engineers. Environmental Effects Committee, eds. Energy production and reservoir water quality: A guide to the regulatory, technical, and theoretical basis for required studies. American Society of Civil Engineers, 2007.

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Liposits, Zsolt. Ultrastructural immunocytochemistry of the hypothalamic corticotropin releasing hormone synthesizing system: Anatomical basis of neuronal and humoral regulatory mechanisms. Gustav Fischer Verlag, 1990.

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Book chapters on the topic "Regulatory basis"

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Rao, Neeraja, and Marilyn J. Telen. "Lutheran Antigens, Lutheran Regulatory Genes, and Lutheran Regulatory Gene Targets." In Molecular Basis of Human Blood Group Antigens. Springer US, 1995. http://dx.doi.org/10.1007/978-1-4757-9537-0_10.

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Pan, Lifeng, Jianping Liu, and Ying Li. "Structural Basis of Autophagy Regulatory Proteins." In Autophagy: Biology and Diseases. Springer Singapore, 2019. http://dx.doi.org/10.1007/978-981-15-0602-4_15.

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Schrader, J. W., K. B. Leslie, I. Clark-Lewis, P. Pitha-Rowe, H. J. Ziltener, and B. F. Fazekas. "Regulatory Polypeptides in the Lympho-Hemopoietic System." In Molecular Basis of Lymphokine Action. Humana Press, 1987. http://dx.doi.org/10.1007/978-1-4612-4598-8_23.

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Collas, Philippe, Sanna Timoskainen, and Agate Noer. "Epigenetic Basis for Differentiation Plasticity in Stem Cells." In Regulatory Networks in Stem Cells. Humana Press, 2009. http://dx.doi.org/10.1007/978-1-60327-227-8_21.

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Dalton, Stephen. "The Molecular Basis of Embryonic Stem Cell Self-Renewal." In Regulatory Networks in Stem Cells. Humana Press, 2009. http://dx.doi.org/10.1007/978-1-60327-227-8_1.

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Burns, Elizabeth M., and Thomas W. Kruckeberg. "The Ultrastructural Basis of Capillary Permeability." In Regulatory Mechanisms of Neuron to Vessel Communication in the Brain. Springer Berlin Heidelberg, 1989. http://dx.doi.org/10.1007/978-3-642-74152-4_1.

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Togashi, Yosuke, and Hiroyoshi Nishikawa. "Regulatory T Cells: Molecular and Cellular Basis for Immunoregulation." In Current Topics in Microbiology and Immunology. Springer International Publishing, 2017. http://dx.doi.org/10.1007/82_2017_58.

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Daniels, Geoff. "Blood Group Antigens as Markers of Complement and Complement Regulatory Molecules." In Molecular Basis of Human Blood Group Antigens. Springer US, 1995. http://dx.doi.org/10.1007/978-1-4757-9537-0_15.

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Redburn, Douglas R. "Scientific, technical and regulatory considerations in environmental management." In Environmental Studies in Port Valdez, Alaska: A Basis for Management. American Geophysical Union, 1988. http://dx.doi.org/10.1029/ln024p0375.

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Kadenbach, B., F. J. Hüther, U. Büge, A. Schlerf, and M. A. Johnson. "Regulatory Complexity of Cytochrome c Oxidase and Its Defective Manifestation in Mitochondrial Diseases." In Molecular Basis of Membrane-Associated Diseases. Springer Berlin Heidelberg, 1989. http://dx.doi.org/10.1007/978-3-642-74415-0_19.

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Conference papers on the topic "Regulatory basis"

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Bisceglia, Bruno, and Simona Valbonesi. "Electromagnetic fields: Scientific basis of regulatory frameworks." In 2017 International Applied Computational Electromagnetics Society Symposium - Italy (ACES). IEEE, 2017. http://dx.doi.org/10.23919/ropaces.2017.7916418.

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Sanchez-Castillo, M., Jia Meng, I. M. Tienda-Luna, and Yufei Huang. "Basis-expansion factor models for uncovering transcription factor regulatory network." In 2012 IEEE Statistical Signal Processing Workshop (SSP). IEEE, 2012. http://dx.doi.org/10.1109/ssp.2012.6319799.

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Lutz, Robert J., and Robert P. Prior. "Comparison of Fukushima Response in the United States and Europe." In 2016 24th International Conference on Nuclear Engineering. American Society of Mechanical Engineers, 2016. http://dx.doi.org/10.1115/icone24-60101.

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The accident at the three reactor units at Fukushima Daiichi showed weaknesses in the plant coping capability for beyond design basis accidents caused by extreme external events. The weaknesses included plant design features, accident management procedures and guidance, and offsite emergency response. As a result, significant changes to plant coping capability have been made to light water reactors worldwide to enhance the coping capabilities for beyond design basis accidents. However, the response in the United States has been significantly different from that in Europe in a number of ways. I

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Iurin, Danil Iurevich. "Regulatory and legal frameworks of outsourcing." In Сollection of articles, chair Liudmila Nikolaevna Ivanova shvets. Publishing house Sreda, 2019. http://dx.doi.org/10.31483/r-32421.

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The article is devoted to the issue of absence of normative basis of outsourcing, the current system of normative regulation of outsourcing activity is investigated, the model of crafting such system in Russia has been offered.

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Pachner, Jaroslav, and Inna V. Kaliberda. "Development of Russian Regulatory Basis for License Renewal/Life Extension of Nuclear Power Plants." In 10th International Conference on Nuclear Engineering. ASMEDC, 2002. http://dx.doi.org/10.1115/icone10-22569.

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By 2010, fifteen Russian nuclear power plant (NPP) units will reach the end of their scheduled service life of 30 years. An extension of NPP operation beyond the scheduled service life, which is provided for by the Russian safety standard OPB-88/97, requires a renewal of the plant operating license by the regulatory organization Gosatomnadzor (GAN). This paper presents an overview of an IAEA project aimed at assisting GAN in the development of a set of regulatory guidelines for NPP license renewal/life extension. The overview includes a description of the Russian regulatory strategy for life e

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Holbrook, Mark R., Jim C. Kinsey, and Wayne L. Moe. "Licensing Basis Event Selection Framework for Advanced Reactors." In ASME 2016 International Mechanical Engineering Congress and Exposition. American Society of Mechanical Engineers, 2016. http://dx.doi.org/10.1115/imece2016-67520.

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This paper describes key aspects of the risk-informed, performance-based licensing methodology as developed by the Department of Energy (DOE) for the Next Generation Nuclear Plant (NGNP) project. The discussion focuses on an event selection process using modular high temperature gas-cooled reactor (HTGR) design attributes and identifies how top-level regulatory criteria can be placed on a frequency-consequence curve. Preliminary Nuclear Regulatory Commission (NRC) staff evaluations concluded that the proposed approach is generally reasonable and responsive to the Commission’s Policy Statement

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Nijhawan, Sunil. "Improved Regulatory Oversight and Immediate Retrofits for Operating Pressurized Heavy Water Reactors for Beyond Design Basis Accidents." In 2012 20th International Conference on Nuclear Engineering and the ASME 2012 Power Conference. American Society of Mechanical Engineers, 2012. http://dx.doi.org/10.1115/icone20-power2012-54387.

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The most painful lessons that engineers will learn from reviews of the Fukushima disaster relates to the unacknowledged failure of regulators, designers and utilities in better retrofitting existing reactors in a timely manner to better withstand and mitigate known severe accident related challenges to reactor and containment integrity. Commercial nuclear power reactors have operated for over 50 years, and the first severe accident progression studies and understanding of related phenomena began to mature over 30 years ago. However, some very basic accident prevention, mitigation and managemen

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Stolyarchuk, Elena Anatolyevna. "Reasons for Choosing Corporate Culture on the Basis of Self-Regulation and Values." In Personal and Regulatory Resources in Achieving Educational and Professional Goals in the Digital Age. European Publisher, 2020. http://dx.doi.org/10.15405/epsbs.2020.10.04.35.

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Nikolaichik, Ye A. "Bacterial transcription factor binding site inference as the basis for the study of plant-microbial interactions." In 2nd International Scientific Conference "Plants and Microbes: the Future of Biotechnology". PLAMIC2020 Organizing committee, 2020. http://dx.doi.org/10.28983/plamic2020.183.

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Genome-wide in silico analysis of bacterial regulatory sequences reveals new regulatory interactions, is generally accessible and should become the standard in the study of plant-microbial interactions.

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Chuangqi, Li. "Regulatory and legal regulation of vocational education institutions on the basis of business partnership." In GLOBAL MODERN TRENDS IN RESEARCH. Baltija Publishing, 2024. http://dx.doi.org/10.30525/978-9934-26-446-7-33.

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Reports on the topic "Regulatory basis"

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Ewing, Paul D., Kofi Korsah, Thomas J. Harrison, Richard Thomas Wood, and Gary T. Mays. Technical Basis for Electromagnetic Compatibility Regulatory Guidance Update. Office of Scientific and Technical Information (OSTI), 2016. http://dx.doi.org/10.2172/1311240.

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Huang, C. H. Unit dose calculation for the K basins safety regulatory assessment feed basis. Office of Scientific and Technical Information (OSTI), 1996. http://dx.doi.org/10.2172/329792.

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Лисоконь, Ілля Олександрович. Regulatory and Legal Basis of Ukraine’s Investment Policy in the Field of Higher Education. Kryvyi Rih State Pedagogical University, 2020. http://dx.doi.org/10.31812/123456789/4269.

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Elaboration and implementation of investment programs for the development of modern universities, cooperation with the business sector, public investment aimed at modernization of the educational environment, implementation of grants, etc. can now be considered as structural components of investment activities of higher education institutions in the context of strategic planning. Therefore, the process of active reform of the educational sector of Ukraine and its integration into the European educational space require a review of approaches, methods and forms of management of education and edu

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Throm, E. D. Regulatory analysis for the resolution of Generic Issue 82, ''Beyond design basis accidents in spent fuel pools''. Office of Scientific and Technical Information (OSTI), 1989. http://dx.doi.org/10.2172/6113293.

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Баттахов, Петр Петрович. ПРАВОВОЕ РЕГУЛИРОВАНИЕ СОЦИАЛЬНО-ЭКОНОМИЧЕСКИХ ОТНОШЕНИЙ В АРКТИЧЕСКОЙ ЗОНЕ. DOI CODE, 2021. http://dx.doi.org/10.18411/1815-1337-2021-11862.

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nomic progress of society. In this case, legal regulation creates favourable conditions and protects the rights of small indigenous northern peoples, that is, the local population, who live permanently in the Arctic zone. Separately, on the basis of this concept, the development of the economy and social sphere of the Arctic bloc as a whole is considered. The main strategic directions for the development of the Arctic and the current regulatory framework of the Russian Federation are being investigated. The author proposes to solve issues related to the socioeconomic problems of the Arctic thr

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Kiefner and Kolovich. PR-218-113605-R01 Evaluation of Regulatory Proposal for Responding to Pipeline Corrosion Metal Loss. Pipeline Research Council International, Inc. (PRCI), 2013. http://dx.doi.org/10.55274/r0010783.

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This report assesses the appropriateness of a regulatory proposal by the Pipeline and Hazardous Materials Safety Administration (PHMSA) for response criteria for corrosion anomalies detected by in-line inspection in non-high-consequence areas (non-HCAs). The proposed response criteria are stricter than those that pipeline operators are currently required to use for anomalies detected in high-consequence areas (HCAs). Presented herein are the results of an evaluation of the technical basis for response criteria for metal-loss anomalies detected by in-line inspection. The evaluation considered u

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Solovyanenko, Nina I. ЮРИДИЧЕСКИЕ СТРАТЕГИИ ЦИФРОВОЙ ТРАНСФОРМАЦИИ АГРАРНОГО БИЗНЕСА. DOI CODE, 2021. http://dx.doi.org/10.18411/0131-5226-2021-70004.

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t.The development of global agricultural production and food trade in recent decades implies a digital transformation and the transition to a new technological order, which is an essential factor for sustainable development. Digitalization of agriculture and the food sector is carried out on the basis of IT 2 platforms, the Internet of Things, cloud computing, big data, artificial intelligence, and blockchain technology. Fragmented and unclear legal mechanisms, slow updating of legal regulation hinder the introduction of digital solutions. A modern regulatory framework based on digital strateg

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O'Donnell, Kevin, and Anne Greene. A Risk Management Solution Designed to Facilitate Risk-Based Qualification, Validation, and Change Control Activities within GMP and Pharmaceutical Regulatory Compliance Environments in the EU—Part II. Institute of Validation Technology, 2006. http://dx.doi.org/10.1080/21506590.wp7142006agko-rmsdii.

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highlight the need for patient-focused and value-adding qualification, validation, and change control programmes for manufacturing and regulating medicinal products in the EU, which are cost-effective and in-line with current regulatory requirements and guidance. To this end, a formal risk management solution was presented that seeks to demonstrate, in a practical way, how Regulators and Industry in the EU may achieve these goals. This solution represents a formal and rigorous approach to risk management, offering a scientific and practical means for determining and managing, on a risk basis,

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O'Donnell, Kevin, and Anne Greene. A Risk Management Solution Designed to Facilitate Risk-Based Qualification, Validation, and Change Control Activities within GMP and Pharmaceutical Regulatory Compliance Environments in the EU—Part I. Institute of Validation Technology, 2006. http://dx.doi.org/10.1080/21506590.wp7132006agko-rmsdfrbq.

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A risk management solution is described that is designed to facilitate risk-based qualification, validation, and change control activities within GMP and regulatory compliance environments in the EU. This solution is based upon a set of pre-defined, fundamental principles and design criteria, which were considered important. It offers a documented and ready-to-use ten-step process for determining and managing, on a risk basis, the scope and extent of qualification and validation, and the likely impact of changes.

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Solovyanenko, Nina I. Legal features of innovative (digital) entrepreneurship in the agricultural and food sector. DOI CODE, 2021. http://dx.doi.org/10.18411/0131-5226-2021-70008.

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Modern agricultural production and food trade are involved in the process of digital transformation, which is a cardinal factor of sustainable development and is carried out on the basis of IT platforms, the Internet of Things, cloud computing, big data, artificial intelligence, blockchain technologies. The COVID-19 pandemic has increased the dependence of these sectors of the economy on information and communication technology infrastructure and services. At the same time, the slow updating of legislation, which lags behind the constantly improving digital technologies, not only hinders their

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