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GMP附录生效前计算机化系统合规策略探讨 被引量:7
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作者 郑茜 严伟民 《上海医药》 CAS 2016年第5期69-71,共3页
《药品生产质量管理规范附件-计算机化系统》是药品生产企业所必需遵循的重要法规之一。对于法规生效之前已经投入使用的计算机化系统,本文参考了欧盟、PIC/S及FDA对此类计算机化系统的要求,结合本人经验提出了系统合规计划的策略。
关键词 法规生效前计算机化系统 设备清单 差距分析
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差距分析法检查GMP附录生效前计算机化系统的合规性 被引量:5
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作者 郑茜 李莺 严伟民 《上海医药》 CAS 2016年第11期78-80,共3页
《药品生产质量管理规范附件-计算机化系统》是药品生产企业所必需遵循的重要法规之一。对于法规生效前的计算机化系统,合规的关键是根据差距分析法提出整改措施。差距分析可根据4大类检查标准,将系统的现状与其进行对比,从而判断系统... 《药品生产质量管理规范附件-计算机化系统》是药品生产企业所必需遵循的重要法规之一。对于法规生效前的计算机化系统,合规的关键是根据差距分析法提出整改措施。差距分析可根据4大类检查标准,将系统的现状与其进行对比,从而判断系统是否符合要求。如检查的结果不符合要求,需进行整改。 展开更多
关键词 法规生效前计算机化系统 差距分析 检查标准 整改建议
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GMP附录生效前计算机化系统合规整改方案 被引量:3
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作者 郑茜 王新玲 严伟民 《上海医药》 CAS 2016年第17期78-80,共3页
《药品生产质量管理规范附录-计算机化系统》是药品生产企业必须遵循的重要法规之一。对法规生效前的计算机化系统,首先应针对计算机化系统生命周期的各阶段要素建立文件体系,其次是根据差距分析识别出缺陷项目,然后再针对缺陷项目进行... 《药品生产质量管理规范附录-计算机化系统》是药品生产企业必须遵循的重要法规之一。对法规生效前的计算机化系统,首先应针对计算机化系统生命周期的各阶段要素建立文件体系,其次是根据差距分析识别出缺陷项目,然后再针对缺陷项目进行逐项整改。本文为操作系统安全、应用程序、备份及备份检查、审计跟踪的整改方案提供参考。 展开更多
关键词 法规生效前计算机化系统 操作系统安全 应用程序 备份及备份检查 审计跟踪
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论缓刑判决生效前又违法的法律适用
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作者 刘敏悦 方敏晔 《社区矫正理论与实践》 2023年第4期3-13,共11页
《中华人民共和国刑法》第77条仅规定了罪犯在缓刑考验期内出现法定情形应予撤销缓刑,并没有规定在缓刑判决生效前又违法应当如何处罚,加之第73条关于“判决确定之日”的表述不严谨,导致实务中对缓刑判决生效前又违法案件的处置方式不... 《中华人民共和国刑法》第77条仅规定了罪犯在缓刑考验期内出现法定情形应予撤销缓刑,并没有规定在缓刑判决生效前又违法应当如何处罚,加之第73条关于“判决确定之日”的表述不严谨,导致实务中对缓刑判决生效前又违法案件的处置方式不一、裁判结果不同。对缓刑判决生效前又违法的法律适用问题应当参照“举轻以明重”的法理,根据《中华人民共和国刑法》第77条第2款的规定予以撤销缓刑收监执行,以彰显法律的权威和尊严,预防社区矫正对象重新违法犯罪。 展开更多
关键词 缓刑 判决生效前 违法 拘留 撤销
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判决生效前立功、漏罪或新罪程序问题研究 被引量:1
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作者 韦宝镇 《中国刑事法杂志》 2000年第5期55-63,共9页
关键词 判决生效前 立功 漏罪 新罪 程序 刑事诉讼
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民事裁判生效前的检察监督探析
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作者 侯华生 《中国检察官》 2015年第7期16-17,共2页
修改后的《民事诉讼法》在司法实践中暴露出民事检察权行使的尴尬与制度上的困难,出现了对民事法官素能最薄弱的基层法院行使民事检察权不充分的问题。从检察监督视角,为最大限度地维护生效民事判决的稳定性和权威性,最大限度地减少案... 修改后的《民事诉讼法》在司法实践中暴露出民事检察权行使的尴尬与制度上的困难,出现了对民事法官素能最薄弱的基层法院行使民事检察权不充分的问题。从检察监督视角,为最大限度地维护生效民事判决的稳定性和权威性,最大限度地减少案件进入再审程序的目的出发,根据现有相关法律、司法解释,可在一审民事裁判生效前进行监督。 展开更多
关键词 基层法院 民事裁判 生效前监督
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附生效条件的赠与合同生效前赠与人死亡的,赠与财产应如何处理
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作者 李勇 《四川审判》 2000年第6期33-33,共1页
关键词 赠与合同 生效条件 生效前 赠与人死亡 合同法
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Integrated Assessment of Trapping Efficiency of Colored Sticky Cards and Sex Pheromone on Liriomyza spp.and Plutella xylostella 被引量:2
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作者 陈祯 郑传伟 +3 位作者 陈旷 戈毅航 刘霞 况荣平 《Agricultural Science & Technology》 CAS 2015年第2期306-310,共5页
[Objective] To evaluate the control effect of yellow sticky cards and sex pheromone on Plutella xylostella and Liriomyza spp.,which can provide reference for large area extension of the technique.[Method] The integrat... [Objective] To evaluate the control effect of yellow sticky cards and sex pheromone on Plutella xylostella and Liriomyza spp.,which can provide reference for large area extension of the technique.[Method] The integrated assessment of trapping efficiency of colored sticky cards and sex pheromone on Liriomyza spp.and Plutella xylostella was conducted by field surveys and structured interview in Tonghai County,Yunnan Province,China.[Result] The results showed that yellow sticky cards and sex pheromone have strong power of trapping Liriomyza spp.and Plutella xylostella(3 414±720 and(219±157) head/piece,respectively);the control cost by the usage of pesticide is the highest,(10 099.5±2 752.5) yuan/hm^2,yellow sticky cards and sex pheromone takes the second place,(1 125.0±465.0) yuan/hm^2,the control cost by the usage of yellow sticky cards is the lowest,(450.0 ±186.0)yuan/hm^2.Without the usage of yellow sticky cards and sex pheromone,pesticide application times and costs are(15.0±2.7) times and(12 070.5±2 136.0) yuan/hm^2;combined with usage of yellow sticky cards and sex pheromone,pesticide application times and costs reduce by 5.7 times and 4 618.5 yuan/hm^2.The ratio of trapped beneficial insects and target pests was 1 ∶1 131,which showed that the negative effect of yellow sticky cards and sex pheromone on the non-target insects was very limited.[Conclusion] The trapping approach has become popular among all the local farmers.Looking at the above factors,the trapping technology has strong application prospect and promotion value in pest control field. 展开更多
关键词 Yellow sticky cards Sex pheromone Liriomyza spp. Plutella xylostella Integrated assessment Ecological impact Trapping efficiency Application prospect
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Determination of Sulphonylurea Glimepiride in Dog Serum by RP-HPLC with Pre-column Derivatization 被引量:1
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作者 卢来春 蒋学华 +1 位作者 周静 杨俊毅 《Journal of Chinese Pharmaceutical Sciences》 CAS 2003年第2期101-105,共5页
Aim A simple, sensitive and rapid RP HPLC method with pre column derivatization has been developed for the determination of sulphonylurea glimepiride in dog serum. Methods The sulphonylurea glimepiride was extract... Aim A simple, sensitive and rapid RP HPLC method with pre column derivatization has been developed for the determination of sulphonylurea glimepiride in dog serum. Methods The sulphonylurea glimepiride was extracted from the dog serum using dichlromethane followed by derivatization with DNBF for 20 min at 100℃. The solvent was then evaporated at 60℃ under nitrogen, and the residue was taken up in 100 μL of mobile phase consisting of acetonitrile water (75∶30, v/v). The separation was performed on a Hypersil BDS C18 column with a flow rate of 0 8 mL·min -1 , and the ultraviolet detector wavelength was set at 350 nm. Results Extraction recovery ranged from 75.9% to 83.2%, and methodological recovery was between 96.5% and 109.3%. Within day RSD ranged from 1.5% to 6.3%, and inter day RSD was between 2 9% and 14.8%. The method showed good linearity (R=0.9998). Conclusion The method was simple, convenient and sensitive. The reaction of derivatization was reproducible. 展开更多
关键词 GLIMEPIRIDE pre column derivatization DNBF serum concentration
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A Pre-column Derivatization HPLC Method for the De-termination of Peimine and Peiminine in Bulbus Fritillar-iae
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作者 李文彦 毕开顺 +2 位作者 乔延江 宁黎丽 罗旭 《Journal of Chinese Pharmaceutical Sciences》 CAS 1996年第4期213-218,共6页
A pre-column derivatization HPLC method for the determination of peimine(P)and peiminine(PE)in Bulbus Fritillariae has been developed. Under the derivatization conditions optimized,the calibration curve is Y1=-3.83... A pre-column derivatization HPLC method for the determination of peimine(P)and peiminine(PE)in Bulbus Fritillariae has been developed. Under the derivatization conditions optimized,the calibration curve is Y1=-3.83×103+1.33 ×105X1,r=0.998 for P and Y2=-7.86 × 102+6.33 × 104X2,r=0995 for PE,where Y is the peak area and X is the weight of the alkaloid; the average recovery is 98.0%(n=5, RSD=2.1%) for P and 101.0%(n=5,RSD=4.1%)for PE,the linear range is from 0.504 μg to 3.126μg for P and from 0.520μgto 3.328μgfor PE,respectively. Results of the determination of the two alkaloids in several samples of different Fritillaria species from various parts ofthe country are presented.The results suggest that P and PE are two major chemical constituents in bulbs of different Fritillaria species,and that the method developed is generally appli-cable to the determination of the hydroxy group on aliphatic fused ring systems without steric hin-drance. 展开更多
关键词 Peimine(P) Peiminine(PE) DERIVATIZATION HPLC
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Pharmacokinetics and Bioavailability of 2-Amino-6-Cyclopropylamino-9-(2,3 -Dideoxy-β-D-glyceropent-2-enofuranosyl) Purine (Cyclo-D4G) in Rats
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作者 刘薏 杨振军 +2 位作者 BOUDINOT F.Douglas CHU Chung Kuang 张礼和 《Journal of Chinese Pharmaceutical Sciences》 CAS 2004年第1期37-41,共5页
AimTo characterize the pharmacokinetics of 2 -amino-6-cyclopropylamino-9-(2,3-dideoxy-β-D-glyceropent-2-enofuran osyl) purine (Cyclo-D4G) following intravenous administration and oral administ ration to rats. Methods... AimTo characterize the pharmacokinetics of 2 -amino-6-cyclopropylamino-9-(2,3-dideoxy-β-D-glyceropent-2-enofuran osyl) purine (Cyclo-D4G) following intravenous administration and oral administ ration to rats. MethodsThe concentrations of Cyclo-D4G in rat (Sprague-Dawley male rats) plasma and urine were analyzed by high performance liquid chromatography (HPLC). ResultsFollowing intravenous adm inistration to rats, concentrations of Cyclo-D4G in plasma declined with a term inal phase half-life of 0 78±0 14 h (±s). Total clearance was 0 90±0 21 L·h -1 ·kg -1 . Renal excretion of unchanged Cyclo-D4G accounted for approximately 20% of total clearance. Steady state volume of distr ibution was 0 91±0 07 L·kg -1 . After oral administration to rats, conce ntrations of Cyclo-D4G in plasma declined with a terminal phase half-life of 0 83±0 13 h (±s). Total clearance was 3 81±2 03 L·h -1 ·kg -1 . Renal excretion of unchanged Cyclo-D4G accounted for approximat ely 9% of total clearance. Oral bioavailability of Cyclo-D4G in rat was 26 9%. ConclusionThe favorable pharmacokinetic profiles and lower to xicity provide support for further development of Cyclo-D4G clinical trials. 展开更多
关键词 PHARMACOKINETICS BIOAVAILABILITY HPLC analysi s D4G prodrug
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The Biological Effect of Hepsin on the Proliferation and Invasion of PC-3 Prostate Cancer Cells
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作者 Yong Xu Zhiqiang Fan +4 位作者 Jantao Sun Ranlu Liu Weiming Zhao Chunyu Wang Ju Zhang 《Chinese Journal of Clinical Oncology》 CSCD 2006年第4期288-291,共4页
OBJECTIVE Recent studies have shown that hepsin, a type of transmembrane serine protease, is highly upregulated in prostate cancer, but, little is known about its role in progression and invasion of this cancer. We co... OBJECTIVE Recent studies have shown that hepsin, a type of transmembrane serine protease, is highly upregulated in prostate cancer, but, little is known about its role in progression and invasion of this cancer. We constructed a hepsin-expressing plasmid and transfected it into PC-3 cells to investigate the effect of the hepsin gene on the biological behavior of the PC-3 cells. METHODS Plasmid pHepsin-IRES2 was transfected into prostate cancer PC-3 cells using Fugene6, and the cells with stable hepsin expression were screened and selected with Zeocin (600 mg/L). The hepsin mRNA level was measured by real-time PCR and the growth curve of the PC-3-transfected cells assessed using MTT and BrdU assays. A Boyden chamber was used to examine the difference in invasion and metastases between transfected and non-transfected cells. RESULTS The hepsin mRNA level in pHepsin-IRES2 transfected -PC-3 cells was significantly higher than that found in the control PC -3 cells. While the growth curve of the hepsin gene transfected PC -3 cells showed that there was no significant effect on proliferation, the invasive ability of the pHepsin-IRES2 transfected PC-3 cells, as compared with control cells, was significantly increased (P<0.05). CONCLUSION The results suggest that even though hepsin has no effect on the proliferation of prostate cancer PC-3 cells, it does promote cellular invasion and metastasis.Therefore hepsin may have a role in the development of prostate cancer. 展开更多
关键词 prostatic neoplasms HEPSIN PROLIFERATION INVASION PC-3 ceils.
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缔约过失责任构成要素解析——由“肯德基秒杀门”引发的法律思考
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作者 刘雪梅 《延边党校学报》 2011年第2期60-61,共2页
缔约过失责任的构成应当包含以下三个要素,即行为发生于合同缔约开始后合同生效前阶段、行为违反先合同义务、造成信赖利益受损。以"肯德基秒杀门"为例,肯德基公司的行为符合缔约过失责任构成要素,因而其不仅应受到道德谴责,... 缔约过失责任的构成应当包含以下三个要素,即行为发生于合同缔约开始后合同生效前阶段、行为违反先合同义务、造成信赖利益受损。以"肯德基秒杀门"为例,肯德基公司的行为符合缔约过失责任构成要素,因而其不仅应受到道德谴责,还应承担相应法律责任。 展开更多
关键词 肯德基秒杀活动 缔约过失责任 合同生效前 先合同义务 信赖利益
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Impacts of Land Fragmentation and Cropping System on the Productivity and Efficiency of Grain Producers in the North China Plain: Taking Cangxian County of Hebei Province as an Example 被引量:3
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作者 WANG Xue LI Xiubin 《Journal of Resources and Ecology》 CSCD 2020年第6期580-588,共9页
Land fragmentation is widely known to have an impact on farm performance. However, previous studies investigating this impact mainly focused on a single crop, and only limited data from China are available. This study... Land fragmentation is widely known to have an impact on farm performance. However, previous studies investigating this impact mainly focused on a single crop, and only limited data from China are available. This study considers multiple crops to identify the impact of land fragmentation(LF), as well as cropping system(CS), on farm productivity and the efficiency of grain producers in the North China Plain(NCP), using Cangxian County of Hebei Province as an example. Detailed household-and plot-level survey data are applied and four stochastic frontier and inefficiency models are developed. These models include different sets of key variables in either the production function or the inefficiency models, in order to investigate all possibilities of their influences on farm productivity and efficiency. The results show that LF plays a significant and detrimental role, affecting both productivity and efficiency. A positive effect is evident with respect to the CS variable, i.e., multiple cropping index(MCI), and the wheat-maize double CS, rather than the maize single CS, is usually associated with higher farm productivity and efficiency. In addition to LF and CS, four basic production input variables(labor, seed, pesticide and irrigation), also significantly affect farmers’ productivity, while the age of the household head and the ratio of the off-farm labor to total labor are significantly relevant to technical inefficiency. Policies geared toward the promotion of land transfer and the rational adjustment of cropping systems are recommended for boosting farm productivity and efficiency, and thus maintaining the food supply while mitigating the overexploitation of groundwater in the NCP. 展开更多
关键词 land fragmentation cropping system stochastic production frontier analysis grain production efficiency North China Plain
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