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药品监管是否以患者利益为中心?

中国医院院长 2022年第19期18卷 21-22页

作者： huseyin naci Reyobin Forrest Courteny Davis 汪奕名(翻译) 宋奇繁(翻译) 不详

MHRA的药品监管制度改革存在问题。2021年7月4日,英国药品与保健品管理局(MHRA)发布2021—2023年工作实施计划《患者利益至上:机构的划时代改革》(Putting Patients First:a New Eraforour Agency)1。在这项计划中,MHRA承诺会让英国的... 详细信息

MHRA的药品监管制度改革存在问题。2021年7月4日,英国药品与保健品管理局(MHRA)发布2021—2023年工作实施计划《患者利益至上:机构的划时代改革》(Putting Patients First:a New Eraforour Agency)1。在这项计划中,MHRA承诺会让英国的药品监督管理工作更好做到以患者为中心,同时也要成为“灵活且能推动行业发展”的监督管理机构,以适应英国生命科学行业的发展利益。

关键词：药品监管制度以患者为中心患者利益监督管理机构生命科学保健品

欧洲药品管理局批准的抗肿瘤药物总生存和生活质量获益证据的可用性:2009-2013年获批药物的回顾性队列研究

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英国医学杂志中文版 2018年第11期21卷 624-624页

作者： Courtney Davis huseyin naci Evrim Gurpinar Elita Poplavska Ashlyn Pinto Ajay Aggarwal 翟婧彤(译) 马飞(校) 不详中国医学科学院肿瘤医院

目的确定欧洲批准的抗肿瘤药物总生存和生活质量获益数据的可用性。设计回顾性队列研究。背景2009-2013年欧洲药品管理局(EMA)公开监管和科学报告的审批药物。主要结局测量抗肿瘤药物上市后临床试验的设计特点(随机、交叉、盲法)... 详细信息

目的确定欧洲批准的抗肿瘤药物总生存和生活质量获益数据的可用性。设计回顾性队列研究。背景2009-2013年欧洲药品管理局(EMA)公开监管和科学报告的审批药物。主要结局测量抗肿瘤药物上市后临床试验的设计特点(随机、交叉、盲法)、参考标准以及研究终点,在审批时和上市后确定的总生存获益或生活质量改善程度和可用性。经验证的欧洲临床肿瘤协会临床获益量表(ESMO-MCBS)用于评估发表的抗肿瘤药物研究报告的生存获益的临床价值。

关键词：抗肿瘤药物药品管理局生活质量队列研究可用性欧洲证据临床试验

药品监管是否以患者利益为中心?MHRA的药品监管制度改革存在问题

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英国医学杂志中文版 2022年第3期25卷 121-123页

作者： huseyin naci Robin Forrest Courtney Davis 汪奕名(译) 宋奇繁(译) Department of Health Policy London School of Economics and Political ScienceUK Department of Global Health and Social Medicine King's College LondonUK 重庆医药高等专科学校

2021年7月4日,英国药品与保健品管理局(MHRA)发布2021-2023年工作实施计划《患者利益至上:机构的划时代改革》(Putting Patients First:a New Era for our Agency)。在这项计划中,MHRA承诺会让英国的药品监督管理工作更好做到以患者为中... 详细信息

2021年7月4日,英国药品与保健品管理局(MHRA)发布2021-2023年工作实施计划《患者利益至上:机构的划时代改革》(Putting Patients First:a New Era for our Agency)。在这项计划中,MHRA承诺会让英国的药品监督管理工作更好做到以患者为中心,同时也要成为“灵活且能推动行业发展”的监督管理机构,以适应英国生命科学行业的发展利益。

关键词：药品监管制度以患者为中心患者利益监督管理机构生命科学保健品

Extremal Problems on Components and Loops in Graphs

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Acta Mathematica Sinica,English Series 2019年第2期35卷 161-171页

作者： Sadik DELEN Ismail naci CANGUL Uludag University Mathematics Department

The authors recently defined a new graph invariant denoted by Ω(G) only in terms of a given degree sequence which is also related to the Euler characteristic. It has many important combinatorial applications in graph theory and gives direct information compared to the better known Euler characteristic on the realizability, connectedness, cyclicness, components, chords, loops etc. Many similar classification problems can be solved by means of Ω. All graphs G so that Ω(G) ≤-4 are shown to be disconnected, and if Ω(G) ≥-2, then the graph is potentially connected. It is also shown that if the realization is a connected graph and Ω(G) =-2, then certainly the graph should be a ***, it is shown that if the realization is a connected graph G and Ω(G) ≥ 0, then certainly the graph should be cyclic. Also, when Ω(G) ≤-4, the components of the disconnected graph could not all be cyclic and if all the components of G are cyclic, then Ω(G) ≥ 0. In this paper, we study an extremal problem regarding graphs. We find the maximum number of loops for three possible classes of *** also state a result giving the maximum number of components amongst all possible realizations of a given degree sequence.

关键词： Graph characteristic connectedness cyclic graph acyclic graph degree sequence

Explicit solutions of nonlinear wave equation systems

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Chinese Physics B 2013年第1期22卷 39-45页

作者： Ahmet Bekir Burcu Ayhan M. naci zer Mathematics and Computer Science Department Eskisehir Osmangazi University

We apply the （G＇/G）-expansion method to solve two systems of nonlinear differential equations and construct traveling wave solutions expressed in terms of hyperbolic functions, trigonometric functions, and rational functions with arbitrary parameters. We highlight the power of the （G＇/G）-expansion method in providing generalized solitary wave solutions of different physical structures. It is shown that the （G＇/G）-expansion method is very effective and provides a powerful mathematical tool to solve nonlinear differential equation systems in mathematical physics.

关键词： (G'/G)-expansion method long-short-wave interaction system coupled integrable dispersionless system

Use of centrifugal-gravity concentration for rejection of talc and recovery improvement in base-metal flotation

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International Journal of Minerals,Metallurgy and Materials 2016年第8期23卷 859-867页

作者： Bern Klein naci Emre Altun Hassan Ghaffari NBK Institute of Mining Engineering The University of British Columbia Department of Mining Engineering Middle East Technical University Tetra Tech Metallurgy

The possibility of using a centrifugal-gravity concentrator to reject Mg-bearing minerals and minimize metal losses in the flotation of base metals was evaluated. Sample characterization, batch scoping tests, pilot-scale tests, and regrind-flotation tests were conducted on a Ni flotation tailings stream. Batch tests revealed that the Mg grade decreased dramatically in the concentrate products. Pilot-scale testing of a continuous centrifugal concentrator（Knelson CVD6） on the flotation tailings revealed that a concentrate with a low mass yield, low Mg content, and high Ni upgrade ratio could be achieved. Under optimum conditions, a concentrate at 6.7% mass yield was obtained with 0.85% Ni grade at 12.9% Ni recovery and with a low Mg distribution（1.7%）. Size partition curves demonstrated that the CVD also operated as a size classifier, enhancing the rejection of talc fines. Overall, the CVD was capable of rejecting Mg-bearing minerals. Moreover, an opportunity exists for the novel use of centrifugal-gravity concentration for scavenging flotation tailings and/or after comminution to minimize amount of Mg-bearing minerals reporting to flotation.

关键词： flotation base metals talc centrifugation gravity concentrators

Quantitative Assessment of Remotely Sensed Global Surface Models Using Various Land Classes Produced from Landsat Data in Istanbul

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Chinese Geographical Science 2014年第3期24卷 307-316页

作者： naci YASTIKLI Umut G SEFERCIK Fatih ESIRTGEN Department of Geomatics Engineering Davutpasa CampusYildiz Technical University Department of Geomatics Engineering Bulent Ecevit University Mescioglu Engineering

Digital elevation model （DEM） is the most popular product for three-dimensional （3D） digital representation of bare Earth surface and can be produced by many techniques with different characteristics and ground sampling distances （GSD）. Space-borne opti- cal and synthetic aperture radar （SAR） imaging are two of the most preferred and modern techniques for DEM generation. Using them, global DEMs that cover almost entire Earth are produced with low cost and time saving processing. In this study, we aimed to assess the Satellite pour robservation de la Terre-5 （SPOT-5）, High Resolution Stereoscopic （HRS）, the Advanced Space-borne Thermal Emission and Reflection Radiometer （ASTER）, and the Shuttle Radar Topography Mission （SRTM） C-band global DEMs, produced with space-borne optical and SAR imaging. For the assessment, a reference DEM derived from 1 ： 1000 scaled digital photogrammetric maps was used. The study is performed in 100 km2 study area in Istanbul including various land classes such as open land, forest, built-up land, scrub and rough terrain obtained from Landsat data. The analyses were realized considering three vertical accuracy types as fundamental, supplemental, and consolidated, defined by national digital elevation program （NDEP） of USA. The results showed that, vertical accuracy of SRTM C-band DEM is better than optical models in all three accuracy types despite having the largest grid spacing. The result of SPOT-5 HRS DEM is very close by SRTM and superior in comparison with ASTER models.

关键词： digital elevation model (DEM) quantitative assessment Satellite pour l'observation de la Terre (SPOT) AdvancedSpace-borne Thermal Emission and Reflection Radiometer (ASTER) Shuttle Radar Topography Mission (SRTM)

Production of 316L stainless steel implant materials by powder metallurgy and investigation of their wear properties

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Chinese Science Bulletin 2012年第15期57卷 1873-1878页

作者： KURGAN naci SUN Yavuz CICEK Bunyamin AHLATCI Hayrettin Engineering Faculty Karabuk University

In this study,the mechanical and wear properties of AISI 316L stainless steel implant materials,produced by powder metallurgy(P/M),were *** 316L stainless steel powder was cold-pressed with 800 MPa of pressure and then sintered at 1200,1250 and 1300°C for 30 min as three sample *** microstructure,and mechanical and wear properties of the resulting steels were *** optical and scanning electron microscopiese were used to characterize the microstructure of the *** temperature mechanical properties of the steels were determined by hardness measurements and impact *** was determined using the pin-on-disc wear test,and the results were evaluated according to weight *** results indicate that the sintering temperature,time and atmosphere are important parameters that affect the porous ratio of materials produced by P/*** at high temperature can eliminate small pores and make the residual pores *** wear tests showed that the wear of the AISI 316L stainless steel implants changed depending on the sintering temperature and *** pores in the samples increase the wear ***,decreasing the porosity ratio of these materials improves all of their mechanical properties.

关键词： 316L不锈钢磨损性能粉末冶金法植入材料冶金生产植入物机械性能烧结温度

Study of Metal and Ceramic Thermionic Vacuum arc Discharges

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Plasma Science and Technology 2007年第3期9卷 280-283页

作者： Tamer AKAN Serdar DEMIRKOL naci EKEM Suat PAT Geavit MUSA Eskisehir Osmangazi University Physics DepartmentEskisehirTurkey National Institute for Laser Plasma and Radiation PhysicsBucharestRomania

The thermionic vacuum arc （TVA） is a new type of plasma source, which generates a pure metal and ceramic vapour plasma containing ions with a directed energy. TVA discharges can be ignited in high vacuum conditions between a heated cathode （electron gun） and an anode （tungsten crucible） containing the material. The accelerated electron beam, incident on the anode, heats the crucible, together with its contents, to a high temperature. After establishing a steadystate density of the evaporating anode material atoms, and when the voltage applied is high enough, a bright discharge is ignited between the electrodes. We generated silver and Al2O3 TVA discharges in order to compare the metal and ceramic TVA discharges. The electrical and optical characteristics of silver and Al2O3 TVA discharges were analysed. The TVA is also a new technique for the deposition of thin films. The film condenses on the sample from the plasma state of the vapour phase of the anode material, generated by a TVA. We deposited silver and Al2O3 thin films onto an aluminium substrate layer-by-layer using their TVA discharges, and produced micro and/or nano-layer Ag-Al2O3 composite samples. The composite samples using scanning electron microscopy was also analysed.

关键词： plasma vacuum arc discharge silver Al2O3 (alumina) composite