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The growth ofβphase in Mg-Gd-Y-Ni alloy by experimental and first-principles study
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作者 Yiqiang Hao Lei Zhou +2 位作者 Zhiqing Chen Zhixian Zhao Bin Chen 《Journal of Magnesium and Alloys》 SCIE EI CAS CSCD 2024年第2期506-515,共10页
The paper reports on the atomic investigation aboutβphase in Mg_(96)Gd_(2)Y_(1)Ni_(1) alloy by using the first-principles study and the high-angle annular dark-field scanning transmission electron microscope(HAADF-ST... The paper reports on the atomic investigation aboutβphase in Mg_(96)Gd_(2)Y_(1)Ni_(1) alloy by using the first-principles study and the high-angle annular dark-field scanning transmission electron microscope(HAADF-STEM)corrected by atomic Cs.By using HAADF-STEM,the rectangularβphases were observed in the underage and peak aging stages in Mg_(96)Gd_(2)Y_(1)Ni_(1) alloy.Theβphase could be precipitated from the previously precipitatedβphase,and theβphase grew in steps when it was precipitated.A special transition structure of three atomic layer thicknesses was first observed at the edge of theβphase and the structure of this interface is probably as theβ/Mg_(1) interface for the analysis of thermodynamic characterization and electronic characterization.Theβ'phase and theβ_(H) structure were precipitated only at the edge of the length directions of theβphase.Theβ'phase continues to grow into aβphase directly without the formation ofβ_(1) phase,resulting in an increase in the length of theβphase,which is discovered for the first time. 展开更多
关键词 HAADF-STEM First-principles study Mg-Gd-Y-Ni alloy βphase GROWTH INTERFACE
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PhaseⅠdose-escalation and expansion study of PARP inhibitor,fluzoparib(SHR3162),in patients with advanced solid tumors 被引量:5
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作者 Huiping Li Rongrui Liu +16 位作者 Bin Shao Ran Ran Guohong Song Ke Wang Yehui Shi Jihong Liu Wenjing Hu Fu Chen Xiaoran Liu Gairong Zhang Chuanhua Zhao Ru Jia Quanren Wang Hope S.Rugo Yifan Zhang Guangze Li Jianming Xu 《Chinese Journal of Cancer Research》 SCIE CAS CSCD 2020年第3期370-382,共13页
Objective:Fluzoparib(SHR3162)is a novel,potent poly(ADP-ribose)polymerases(PARP)1,2 inhibitor that showed anti-tumor activity in xenograft models.We conducted a phaseⅠ,first-in-human,dose-escalation and expansion(D-E... Objective:Fluzoparib(SHR3162)is a novel,potent poly(ADP-ribose)polymerases(PARP)1,2 inhibitor that showed anti-tumor activity in xenograft models.We conducted a phaseⅠ,first-in-human,dose-escalation and expansion(D-Esc and D-Ex)trial in patients with advanced solid cancer.Methods:This was a 3+3 phaseⅠD-Esc trial with a 3-level D-Ex at 5 hospitals in China.Eligible patients for DEsc had advanced solid tumors refractory to standard therapies,and D-Ex enrolled patients with ovarian cancer(OC).Fluzoparib was administered orally once or twice daily(bid)at 11 dose levels from 10 to 400 mg/d.Endpoints included dose-finding,safety,pharmacokinetics,and antitumor activity.Results:Seventy-nine patients were enrolled from March,2015 to January,2018[OC(47,59.5%);breast cancer(BC)(16,20.3%);colorectal cancer(8,10.1%),other tumors(8,10.1%)];48 patients were treated in the D-Esc arm and 31 in the D-Ex arm.The maximum tolerated dose(MTD)was 150 mg bid,with a half-life of 9.14 h.Grade 3/4 adverse events included anemia(7.6%)and neutropenia(5.1%).The objective response rate(ORR)was 30%(3/10)in patients with platinum-sensitive OC and 7.7%(1/13)in patients with BC.Among patients treated with fluzoparib≥120 mg/d,median progression-free survival(m PFS)was 7.2[95%confidence interval(95%CI),1.8-9.3]months in OC,9.3(95%CI,7.2-9.3)months in platinum-sensitive OC,and 3.5(range,2.0-28.0)months in BC.In patients with germline BC susceptibility gene mutation(g BRCAMut)(11/43 OC;2/16 BC),m PFS was 8.9 months for OC(range,1.0-23.2;95%CI,1.0-16.8)and 14 and 28 months for BC(those two patients both also had somatic BRCAMut).Conclusions:The MTD of fluzoparib was 150 mg bid in advanced solid malignancies.Fluzoparib demonstrated single-agent antitumor activity in BC and OC,particularly in BRCAMut and platinum-sensitive OC. 展开更多
关键词 phase PARP inhibitor(fluzoparib) solid tumor PHARMACOKINETICS SAFETY antitumor activity
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First-principles study on stability and superconductivity of ternary hydride LaYH_(x)(x=2,3,6 and 8)
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作者 颜小珍 周幸姿 +4 位作者 刘超飞 徐寅力 黄毅斌 盛晓伟 陈杨梅 《Chinese Physics B》 SCIE EI CAS CSCD 2024年第8期415-420,共6页
Recent studies have shown that the La-and Y-hydrides can exhibit significant superconducting properties under high pressures.In this paper,we investigate the stability,electronic and superconducting properties of LaYH... Recent studies have shown that the La-and Y-hydrides can exhibit significant superconducting properties under high pressures.In this paper,we investigate the stability,electronic and superconducting properties of LaYH_(x)(x=2,3,6 and 8)under 0-200 GPa.It is found that LaYH_(2) stabilizes in the C2/m phase at ambient pressure,and transforms to the Pmmn phase at 67 GPa.LaYH_(3) stabilizes in the C2/m phase at ambient pressure,and undergoes phase transitions of C2/m→P2_(1)/m→R3m at 12 GPa and 87 GPa,respectively.LaYH_(6) stabilizes in the P4_32_12 phase at ambient pressure,and undergoes phase transitions of P4_(3)2_(1)2→P4/mmm→Cmcm at 28 GPa and 79 GPa,respectively.LaYH_(8) stabilizes in the Imma phase at 60 GPa and transforms to the P4/mmm phase at 117 GPa.Calculations of the electronic band structures show that the P4/mmm-LaYH_(8) and all phases of LaYH_(2) and LaYH_(3) exhibit metallic character.For the metallic phases,we then study their superconducting properties.The calculated superconducting transition temperatures(T_c)are 0.47 K for C2/m-LaYH_(2) at 0 GPa,0 K for C2/m-LaYH_(3) at 0 GPa,and 55.51 K for P4/mmm-LaYH_(8) at 50 GPa. 展开更多
关键词 SUPERCONDUCTIVITY high pressure first-principles study phase transitions
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Pharmacological intervention for chronic phase of spinal cord injury
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作者 Chihiro Tohda 《Neural Regeneration Research》 SCIE CAS 2025年第5期1377-1389,共13页
Spinal cord injury is an intractable traumatic injury. The most common hurdles faced during spinal cord injury are failure of axonal regrowth and reconnection to target sites. These also tend to be the most challengin... Spinal cord injury is an intractable traumatic injury. The most common hurdles faced during spinal cord injury are failure of axonal regrowth and reconnection to target sites. These also tend to be the most challenging issues in spinal cord injury. As spinal cord injury progresses to the chronic phase, lost motor and sensory functions are not recovered. Several reasons may be attributed to the failure of recovery from chronic spinal cord injury. These include factors that inhibit axonal growth such as activated astrocytes, chondroitin sulfate proteoglycan, myelin-associated proteins, inflammatory microglia, and fibroblasts that accumulate at lesion sites. Skeletal muscle atrophy due to denervation is another chronic and detrimental spinal cord injury–specific condition. Although several intervention strategies based on multiple outlooks have been attempted for treating spinal cord injury, few approaches have been successful. To treat chronic spinal cord injury, neural cells or tissue substitutes may need to be supplied in the cavity area to enable possible axonal growth. Additionally, stimulating axonal growth activity by extrinsic factors is extremely important and essential for maintaining the remaining host neurons and transplanted neurons. This review focuses on pharmacotherapeutic approaches using small compounds and proteins to enable axonal growth in chronic spinal cord injury. This review presents some of these candidates that have shown promising outcomes in basic research(in vivo animal studies) and clinical trials: AA-NgR(310)ecto-Fc(AXER-204), fasudil, phosphatase and tensin homolog protein antagonist peptide 4, chondroitinase ABC, intracellular sigma peptide,(-)-epigallocatechin gallate, matrine, acteoside, pyrvate kinase M2, diosgenin, granulocyte-colony stimulating factor, and fampridine-sustained release. Although the current situation suggests that drug-based therapies to recover function in chronic spinal cord injury are limited, potential candidates have been identified through basic research, and these candidates may be subjects of clinical studies in the future. Moreover, cocktail therapy comprising drugs with varied underlying mechanisms may be effective in treating the refractory status of chronic spinal cord injury. 展开更多
关键词 axonal growth chronic phase clinical study PHARMACOTHERAPY spinal cord injury
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A phase I study of different doses and frequencies of pegylated recombinant human granulocyte-colony stimulating factor(PEG rhG-CSF) in patients with standard-dose chemotherapy-induced neutropenia 被引量:11
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作者 Yan Qin Xiaohong Han +7 位作者 Lin Wang Ping Du Jiarui Yao Di Wu Yuanyuan Song Shuxiang Zhang Le Tang Yuankai Shi 《Chinese Journal of Cancer Research》 SCIE CAS CSCD 2017年第5期402-410,共9页
Objective: The recommended dose of prophylactic pegylated recombinant human granulocyte-colony stimulating factor(PEG rhG-CSF) is 100 μg/kg once per cycle for patients receiving intense-dose chemotherapy.However, ... Objective: The recommended dose of prophylactic pegylated recombinant human granulocyte-colony stimulating factor(PEG rhG-CSF) is 100 μg/kg once per cycle for patients receiving intense-dose chemotherapy.However, few data are available on the proper dose for patients receiving less-intense chemotherapy. The aim of this phase I study is to explore the proper dose and administration schedule of PEG rhG-CSF for patients receiving standard-dose chemotherapy.Methods:Eligible patients received 3-cycle chemotherapy every 3 weeks.No PEG rhG-CSF was given in the first cycle.Patients experienced grade 3 or 4 neutropenia would then enter the cycle 2 and 3.In cycle 2,patients received a single subcutaneous injection of prophylactic PEG rhG-CSF on d 3,and received half-dose subcutaneous injection in cycle 3 on d 3 and d 5,respectively.Escalating doses(30,60,100 and 200μg/kg)of PEG rhG-CSF were investigated.Results:A total of 26 patients were enrolled and received chemotherapy,in which 24 and 18 patients entered cycle 2 and cycle 3 treatment,respectively.In cycle 2,the incidence of grade 3 or 4 neutropenia for patients receiving single-dose PEG rhG-CSF of 30,60,100 and 200 μg/kg was 66.67%,33.33%,22.22% and 0,respectively,with a median duration less than 1(0–2)d.No grade 3 or higher neutropenia was noted in cycle 3 in all dose cohorts.Conclusions:The pharmacokinetic and pharmacodynamic profiles of PEG rhG-CSF used in cancer patients were similar to those reported,as well as the safety.Double half dose administration model showed better efficacy result than a single dose model in terms of grade 3 neutropenia and above.The single dose of 60 μg/kg,100 μg/kg and double half dose of 30 μg/kg were recommended to the phase Ⅱ study,hoping to find a preferable method for neutropenia treatment. 展开更多
关键词 phase study chemotherapy dose-finding neutropenia PEG rhG-CSF
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强组合PhaseⅠ-PhaseⅡ次可行方向法 被引量:7
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作者 简金宝 《经济数学》 1995年第1期64-70,共7页
本文对Polak等人的组合NaseⅠ-Ⅱ可行方向法进行改进,使之不仅能自动地将初始化阶段(Phasel)和最优化阶段(PhaseⅡ)统一起来,而且保证了满足不等式约束的函数个数不断叠累递增,故称改进后的算法为强组合P... 本文对Polak等人的组合NaseⅠ-Ⅱ可行方向法进行改进,使之不仅能自动地将初始化阶段(Phasel)和最优化阶段(PhaseⅡ)统一起来,而且保证了满足不等式约束的函数个数不断叠累递增,故称改进后的算法为强组合PhaseⅠ-ⅡPhaseⅡ次可行方向法.本文算法包含了一种新的目标局数非单词的非精确线搜索,它保证了算法产生的点列的任何聚点都是问题的K-T的点. 展开更多
关键词 非线性规划 强组合phase-phase 可行方向法 非单调线搜索 整体收敛性
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Safety and Tolerance of Adefovir Dipivoxil in Chinese Healthy Volunteers: A PhaseⅠRandomized and Open-Label Trial
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作者 孙德清 倪梅媛 +1 位作者 王本杰 郭瑞臣 《Journal of Chinese Pharmaceutical Sciences》 CAS 2005年第4期217-222,共6页
Aim To assess the safety and tolerance of adefovir dipivoxil (ADV) in Chinese healthy volunteers. Methods A total of 52 healthy volunteers, 26 males and 26 females, aged from 19 to 26 were enrolled in the study. For... Aim To assess the safety and tolerance of adefovir dipivoxil (ADV) in Chinese healthy volunteers. Methods A total of 52 healthy volunteers, 26 males and 26 females, aged from 19 to 26 were enrolled in the study. Forty-two subjects were randomized into 5, 10, 20, 40, and 60 mg dose groups (6 - 10 subjects in each) matched by sex and weight for single-dose trial. Ten subjects were orally given 10 mg of ADV tablets once daily for 7 d for multiple-dose trial. Physical examination, vital signs examination, electrocardiography, type-B ultrasonography, chest fluoroscopy, routine blood test, routine urine test, coagulation tests, and blood biochemical test were conducted on schedule and statistically evaluated. Results Asthenia frequently occurred in multiple-dose trial, nausea, abdominal pain, and diarrhea occurred in both single- and multiple-dose trials. ALT, bilirubin, CK, and LDH were slightly elevated. All adverse reactions and laboratory abnormalities were mild, and the frequency and severity were not related to doses. Conclusion ADV is safe and well tolerated in Chinese healthy volunteers at dose of 5 - 60 mg oncedaily or 10 nag once daily for 7 d. The recommended oral dosage regimen is 10 mg once daily. Attention should be paid to renal and liver functions, CK, AMY and LDH, if we take ADV for a long period of time. 展开更多
关键词 adefovir dipivoxil SAFETY TOLERANCE phasetrial
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Human umbilical cord mesenchymal stem cells to treat spinal cord injury in the early chronic phase: study protocol for a prospective, multicenter, randomized, placebo-controlled, single-blinded clinical trial 被引量:9
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作者 Yang Yang Mao Pang +5 位作者 Yu-Yong Chen Liang-Ming Zhang Hao Liu Jun Tan Bin Liu Li-Min Rong 《Neural Regeneration Research》 SCIE CAS CSCD 2020年第8期1532-1538,共7页
Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promisin... Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promising candidate for the treatment of intractable spinal cord injury(SCI).Clinical studies on patients with early chronic SCI(from 2 months to 1 year post-injury),which is clinically common,are rare;therefore,we will conduct a prospective,multicenter,randomized,placebo-controlled,single-blinded clinical trial at the Third Affiliated Hospital of Sun Yat-sen University,West China Hospital of Sichuan University,and Shanghai East Hospital,Tongji University School of Medicine,China.The trial plans to recruit 66 early chronic SCI patients.Eligible patients will undergo randomization at a 2:1 ratio to two arms:the observation group and the control group.Subjects in the observation group will receive four intrathecal transplantations of stem cells,with a dosage of 1×106/kg,at one calendar month intervals.Subjects in the control group will receive intrathecal administrations of 10 mL sterile normal saline in place of the stem cell transplantations.Clinical safety will be assessed by the analysis of adverse events and laboratory tests.The American Spinal Injury Association(ASIA)total score will be the primary efficacy endpoint,and the secondary efficacy outcomes will be the following:ASIA impairment scale,International Association of Neural Restoration-Spinal Cord Injury Functional Rating Scale,muscle tension,electromyogram,cortical motor and cortical sensory evoked potentials,residual urine volume,magnetic resonance imaging–diffusion tensor imaging,T cell subtypes in serum,neurotrophic factors and inflammatory factors in both serum and cerebrospinal fluid.All evaluations will be performed at 1,3,6,and 12 months following the final intrathecal administration.During the entire study procedure,all adverse events will be reported as soon as they are noted.This trial is designed to evaluate the clinical safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.Moreover,it will establish whether cytotherapy can ameliorate local hostile microenvironments,promote tracking fiber regeneration,and strengthen spinal conduction ability,thus improving overall motor,sensory,and micturition/defecation function in patients with early chronic SCI.This study was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2018]-02)on March 30,2018,and was registered with ClinicalTrials.gov(registration No.NCT03521323)on April 12,2018.The revised trial protocol(protocol version 4.0)was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2019]-10)on February 25,2019,and released on ClinicalTrials.gov on April 29,2019. 展开更多
关键词 clinical study early chronic phase efficacy human umbilical cord mesenchymal stem cell multicenter trial prospective study randomized controlled trial safety spinal cord injury study protocol
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Phase I study of chimeric anti-CD20 monoclonal antibody in Chinese patients with CD20-positive non-Hodgkin's lymphoma 被引量:6
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作者 Lin Gui Xiaohong Han +10 位作者 Xiaohui He Yuanyuan Song Jiarui Yao Jianliang Yang Peng Liu Yan Qin Shuxiang Zhang Weijing Zhang Wenlin Gai Liangzhi Xie Yuankai Shi 《Chinese Journal of Cancer Research》 SCIE CAS CSCD 2016年第2期197-208,共12页
Objective: This study was designed to determine the safety, pharmacokinetics and biologic effects of a humanmouse chimeric anti-CD20 monoclonal antibody (SCT400) in Chinese padents with CD20-positive B-cell non- Ho... Objective: This study was designed to determine the safety, pharmacokinetics and biologic effects of a humanmouse chimeric anti-CD20 monoclonal antibody (SCT400) in Chinese padents with CD20-positive B-cell non- Hodgkin's lymphoma (CD20 B-cell NHL). SCT400 has an identical amino acid sequence as rituximab, with the exception of one amino acid in the CH1 domain of the heavy chain, which is common in Asians. Methods: Fifteen patients with CD20+ B-cell NHL received dose-escalating SCT400 infusions (250 mg/m2: n=3; 375 mg/m2: n=9; 500 mg/m2: n=3) once weekly for 4 consecutive weeks with a 24-week follow-up period. The data of all patients were collected for pharmacoklnetics and pharmacodynamics analyses. Results: No dose-limiting toxicities were observed. Most drug-related adverse events were grade 1 or 2. Two patients had grade 3 or 4 ncutropenia. Under premedication, the drug-related infusion reaction was mild. A rapid, profound and durable depletion of circulating B cells was observed in all dose groups without significant effects on T cell count, natural killer (NK) cell count or immunoglobulin levels. No patient developed anti- SCT400 antibodies during the course of the study. SCT400 serum half-life (Tin), maximum concentration (Cmax and area under the curve (AUC) generally increased between the first and fourth infusions (P〈0.05). At the 375 mg/m2 dose, the T1/2 was 122.5±46.7 h vs. 197.0,75.0 11, respectively, and the Cmax was 200.6±20.2 pg/mL vs. 339.1±71.0 ng/mL, respectively. From 250 mg/m2 to 500 mg/m2, the Cmax and AUC increased significantly in a dose-dependent manner (P〈0.05). Patients with a high tumor burden had markedly lower serum SCT400 concenmations compared with those without or with a low tumor burden. Of the 9 assessable patients, 1 achieved complete response and 2 achieved partial responses. Conclusions; SCT400 is well-tolerated and has encouraging preliminary efficacy in Chinese patients with CD20+ B-cell NHL. 展开更多
关键词 Chimeric anti-CD20 monodonal antibody non-Hodgldn's lymphoma phase I study
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Dynamic Study of Polymer Particle Growth in Gas Phase Polymerization of Butadiene 被引量:2
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作者 孙建中 何斯征 周其云 《Chinese Journal of Chemical Engineering》 SCIE EI CAS CSCD 2001年第2期217-220,共4页
An experimental apparatus composed of microscope, video camera. image-processing, and mini reactor which can be used for real-time measurement of the growth of polymer particle in gas phase polymerization was built up... An experimental apparatus composed of microscope, video camera. image-processing, and mini reactor which can be used for real-time measurement of the growth of polymer particle in gas phase polymerization was built up to carry out dynamic study of gas phase polymerization of butadiene by heterogeneous catalyst based on neodymium(Nd). The studies of the shape duplication of polymer particles and catalyst particles and the growth rate of polymer particle were made. Results show that the apparatus and procedure designed can be well utilized to make dynamic observation and data collection of the growth of polymer particle in gas phase polymerization. A phenomenon of shape duplication of polymer particles and catalyst particles was observed by the real-time measurement. The result also concludes that the activity of individual catalyst particle is different, and the effect of reaction pressure on the growth of polymer particle is significant. 展开更多
关键词 gas phase polymerization BUTADIENE particle growth dynamic study
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Study on the Miscibility and Phase Behavior of Polyoxymethylene with Novolak 被引量:1
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作者 Xiaodong WANG, Hangquan LI and Riguang JIN (School of Materials Science and Engineering, Beijing University of Chemical Technology, Beijing 100029, China) 《Journal of Materials Science & Technology》 SCIE EI CAS CSCD 2000年第4期427-430,共4页
The miscibility and phase behavior of the blends of polyoxymethylene (POM)/Novolak were investigated by the cloud point method, which showed that the POM/Novolak blends exhibited a lower critical solution temperature.... The miscibility and phase behavior of the blends of polyoxymethylene (POM)/Novolak were investigated by the cloud point method, which showed that the POM/Novolak blends exhibited a lower critical solution temperature. The melting point of POM decreased when diluted with Novolak. From the melting temperature depression of POM, a negative interaction parameter (x) between POM and Novolak was obtained. The IR spectrum revealed that the miscibility between POM and Novolak was caused by the specific interaction between the OH groups of Novolak and the ether oxygen atoms of POM. The morphology of the blends investigated by polarized light microscopy showed that the size of spherulites of POM was sharply decreased by its mixing with Novolak. This suggests that Novolak be used as a compatibilizer for POM. 展开更多
关键词 POM study on the Miscibility and phase Behavior of Polyoxymethylene with Novolak
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Phase Evolution and Magnetic Studies of La and Refractory Metals Co-substituted α-Fe/R_2Fe_(14)B-type Nanocomposites 被引量:1
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作者 W. C. Changt, S.H. Wang, S.J. Chang and M. Y. Tsai (Department of Physics, Chung Cheng University, Ming-Hsiung, Chia-Yi, 621, Taiwan-China Q.Chen) (Rhodia Inc., Rare Earths and Gallium, CN 7500, Cranbury, New Jersey 08512, U.S.A.) 《Journal of Materials Science & Technology》 SCIE EI CAS CSCD 2000年第2期102-106,共5页
Phase evolution and magnetic properties of (Nd_o.95La_0.05)9.5-11Febal.M_2B10.5. where M=Cr, Ti, Nb, V, Mo, Zr, Hf, Ta, Mn or W, melt spun ribbons have been investigated. Almost all the alloy ribbons. except for(Nd_0.... Phase evolution and magnetic properties of (Nd_o.95La_0.05)9.5-11Febal.M_2B10.5. where M=Cr, Ti, Nb, V, Mo, Zr, Hf, Ta, Mn or W, melt spun ribbons have been investigated. Almost all the alloy ribbons. except for(Nd_0.95La_0.05)_9.5Fe_78M_2B_10.5(M=Mo and Mn),consist merely two magnetic phases, namely α-Fe and R_2Fe_14B, which display a better combination of _iH_c and magnetic energy product. Remanence (Br) and coercivity (i_H_c) values in the range of 8.0 to 9.1 kG and 9.5 to 18.9 kOe. respectively, can be achieved. Among compositions studied, the Ti and W-substitutions were found to be most effective in increasing the Br and i_H_c, respectively. For a fixed refractory metal substitution, namely, M=C_r, Ti or Nb, an increase in the total rare earth concentration resulted in nanocomposites of small grain sizes and a high volume fraction of the R_2Fe_14B phase, leading to an increase in the magnetic properties. 展开更多
关键词 Fe/R2Fe B-type Nanocomposites phase Evolution and Magnetic Studies of La and Refractory Metals Co-substituted TYPE LA
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Specification of phase Ⅰ of new drugs' clinical tolerance trials
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作者 LI Guo-xin(Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Liaoning Province Academy of Traditional Chinese Medicine,Shenyang 110034,China) 《沈阳药科大学学报》 CAS CSCD 北大核心 2008年第S1期14-14,共1页
Phase Ⅰ of clinical trials is the first stage of clinical pharmacology and body safety evaluation,including body tolerance test and pharmacokinetics test.The aim is providing evidence for dosage regimen and be the co... Phase Ⅰ of clinical trials is the first stage of clinical pharmacology and body safety evaluation,including body tolerance test and pharmacokinetics test.The aim is providing evidence for dosage regimen and be the cornerstone of the preliminary assessment of efficacy and safety of phase Ⅱ of clinical trials.This text discussed the technique and requirement of phase Ⅰ of new drugs' clinical tolerance trials. 展开更多
关键词 CLINICAL TOLERANCE trials phase
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Study and ICH validation of a reverse-phase liquid chromatographic method for the quantification of the intact monoclonal antibody cetuximab 被引量:1
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作者 Antonio Martinez-Ortega Agustin Herrera +3 位作者 Antonio Salmeron-Garcia Jose Cabeza Luis Cuadros-Rodriguez Natalia Navas 《Journal of Pharmaceutical Analysis》 SCIE CAS 2016年第2期117-124,共8页
Cetuximab (CTX) is a potent chimeric mouse/human monoclonal antibody (mAb) approved worldwide for treatment of metastatic colorectal cancer. Among the various biological and physical analyses per- formed for full ... Cetuximab (CTX) is a potent chimeric mouse/human monoclonal antibody (mAb) approved worldwide for treatment of metastatic colorectal cancer. Among the various biological and physical analyses per- formed for full study on this biopharmaceutic, the determination of the concentration preparations throughout manufacturing and subsequent handling in hospital is particularly relevant. In the present work, the study and validation of a method for quantifying intact CTX by reverse-phase high-perfor- mance liquid chromatography with diode array detection ((RP)HPLC/DAD) is presented. With that end, we checked the performance of a chromatographic method for quantifying CTX and conducted a study to validate the method as stability-indicating in accordance with the International Conference on Harmo- nization guidelines (ICH) for biotechnological drugs; therefore, we evaluated linearity, accuracy, preci- sion, detection and quantification limits, robustness and system suitability. The specificity of the method and the robustness of the mAb formulation against external stress factors were estimated by compre- hensive chromatographic analysis by subjecting CTX to several informative stress conditions. As de- monstrated, the method is rapid, accurate, and reproducible for CTX quantification. It was also suc- cessfully used to quantify CTX in a long-term stability study performed under hospital conditions. 展开更多
关键词 Reverse-phase high performance liquidchromatography Diode detector Stress study BIOPHARMACEUTICALS CETUXIMAB
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A phase I study with Satraplatin and simultaneous chest radiation for non-small cell lung cancer
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作者 Puneeth Iyengar Joseph C. Hodges +4 位作者 Randall Hughes Michael DiMaio Michael Petrone Soyong Yun Hak Choy 《Advances in Lung Cancer》 2012年第3期13-19,共7页
Introduction: Satraplatin has been given in combination therapy for lung cancer to utilize its radio-sensitizing properties. The optimal dose of satra-platin given concurrently with radiation therapy for locally advan... Introduction: Satraplatin has been given in combination therapy for lung cancer to utilize its radio-sensitizing properties. The optimal dose of satra-platin given concurrently with radiation therapy for locally advanced non-small cell lung cancer (NSC-LC) has not been defined. This phase I trial attempts to identify a maximally tolerated dose (MTD) and dose limiting toxicity (DLT) for Satraplatin given con-currently with radiation for locally advanced N-SCLC. Patients and Methods: 15 patients with histologically confirmed Stage IIIA/B NSCLC entered onto this study with four dose escalations (10 to 40 mg daily) of Satraplatin. Eligibility included patients with NSCLC and one of the following criteria: 1) previously untreated, inoperable disease and planned to receive radiation therapy to primary disease site;2) previously resected disease with mediastinal relapse;or 3) metastatic disease in no more than one distant site. Results: The most common toxicities reported were all grades of fatigue (n = 9), nausea (n = 9), constipation (n = 7), fever (n = 7), and vomiting (n = 6). No DLT at the 1st, 2nd, and 3rd dose levels was identified. At the 4th dose level, one patient developed grade III elevation of liver function tests (LFTs) and a second patient developed grade III diarrhea with fever requiring hospitalization. There were 8 partial responses out of 11 evaluable patients for response (RR 67%). Conclusion: Elevated LFTs and diarrhea appear to be the principal DLTs of concurrent daily oral Satraplatin and thoracic radiation in the outpatient setting. The MTD of concurrent Satraplatin with thoracic radiation therapy appears to be 40 mg daily. 展开更多
关键词 NON-SMALL Cell LUNG Cancer CHEMORADIATION SATRAPLATIN phase I study TOXICITY
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A Phase II Study of Erlotinib in Patients with Previously Treated Non-Small Cell Lung Cancer
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作者 Tetsuya Kubota Yoshio Okano +9 位作者 Mizu Sakai Takashi Yamane Naoki Shiota Hiroshi Ohnishi Hisanori Machida Nobuo Hatakeyama Eiji Takeuchi Tomoyuki Urata Fumitaka Ogushi Akihito Yokoyama 《Advances in Lung Cancer》 2014年第1期10-20,共11页
Background: Erlotinib has been reported to be effective for the treatment of non-small cell lung cancer (NSCLC). To evaluate the efficacy and safety of erlotinib under conditions similar to daily clinical practice, a ... Background: Erlotinib has been reported to be effective for the treatment of non-small cell lung cancer (NSCLC). To evaluate the efficacy and safety of erlotinib under conditions similar to daily clinical practice, a phase II trial was conducted in Japanese patients with previously treated NSCLC. Methods: The eligibility criteria were stage IIIB/IV NSCLC, a performance status (PS) of 0 - 2, and previous treatment with 1 - 2 non-EGFR-TKI regimens. Patients received erlotinib (150 mg/day) orally until disease progression or intolerable toxicity occurred. The primary endpoint was the objective response rate (ORR). In addition, the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety, and EGFR gene mutation status were evaluated. Results: Thirty-eight patients were enrolled, and 37 patients were evaluated. The median age was 69 years (range, 50 - 80 years). Patient characteristics were as follows: 26 were male and 11 were female;12 had a PS of 0, 20 had a PS of 1, and 5 had a PS of 2;and 26 had adenocarcinoma, and 11 had non-adenocarcinoma histology. The ORR and DCR were 21.6% (95% confidence interval [CI], 11.4% - 37.2%) and 54.1% (95% CI, 35.9% - 66.6%), respectively. Twenty-seven patients could be evaluated for EGFR gene status (12, mutated;15, wild-type). The ORR for EGFR-mutated patients was 41.7%, while that for patients with wild-type EGFR was 13.3%. The median PFS was evaluated as 4.4 months (95% CI, 2.2 - 10.7 months). The median OS was 14.9 months (95% CI, 9.2 months - not reached). Common adverse events were tolerable skin toxicities, diarrhea, and stomatitis. In addition, interstitial lung disease occurred in 8.1% of patients. Conclusion: As efficacy and safety were similar to previous studies, erlotinib was found to be effective for Japanese patients with previously treated NSCLC in clinical practice. 展开更多
关键词 NON-SMALL CELL LUNG CANCER phase II study ERLOTINIB Previously TREATED
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Phase Ⅱ study of mitomycin C and cisplatin in heavily pretreated advanced breast cancer
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作者 Xichun Hu Haiyi Guo Xinmin Zhao Zhonghua Wang Xinmiao Yang Xiangjin Liu Jin Li 《The Chinese-German Journal of Clinical Oncology》 CAS 2006年第6期442-445,共4页
Objective: The mitomycin C and cisplatin combination was investigated in patients with advanced breast cancer who had been exposed to anthracyclines, vinorelbine and taxanes. Methods: Three-weekly regimen consisted ... Objective: The mitomycin C and cisplatin combination was investigated in patients with advanced breast cancer who had been exposed to anthracyclines, vinorelbine and taxanes. Methods: Three-weekly regimen consisted of mitomycin, 6 mg/m^2 administered intravenously on day 1, and cisplatin, 25 mg/m^2 intravenously on day 1-3. Results: Thirty-eight patients aged 25-75 years (median, 46 years) were treated with an overall response rate of 31.6%. The median time to progression (TTP) was 4.0 months. Median TTP for 12 patients with a complete or partial response was 9.0 months, while stable disease and progression of disease 4.0 months, P=0.002. Grade 3/4 side effects of neutropenia, thrombocytopenia and nausea/vomiting were documented in 4 (10.5%), 4 (10.5%) and 3 (7.9%) patients, respectively. The median overall survival was 13* months. Conclusion: Mitomydn C/cisplatin doublet showed antitumor activity for anthracydine-, vinorelbine- and taxane-resistant breast cancer comparable to other regimens. This well-tolerated regimen provides an affordable option for patients in China. 展开更多
关键词 mitomycin C CISPLATIN phase II study breast cancer
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Studies on Solid-Liquid Phase Transfer Equilibrium of Onium Salts(Ⅱ)
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作者 Zhao Yingying and Zheng Luo (Department of Chemistry, Jilin University, Changchun)Shen Yusheng (Department of Chemistry, South-Central College for Nationalities, Wuhan) 《Chemical Research in Chinese Universities》 SCIE CAS CSCD 1992年第1期5-9,共5页
The present paper contains the effects of the ammonium ion, counter ion, solvent and anion being transferred on the solid-liquid phase transfer equilibrium constant of quaternary ammonium salts. The most striking diff... The present paper contains the effects of the ammonium ion, counter ion, solvent and anion being transferred on the solid-liquid phase transfer equilibrium constant of quaternary ammonium salts. The most striking difference between solid-liquid and liquid-liquid phase transfer equilibriums is that the length of alkyl chain shows a large effect on the latter but little on the former This means that the chain length affects only the hydrophobicity, rather than the lipophilicity.Keywords Quaternary ammonium salt, Phase transfer catalysis, Equilibrium constant, Hydrophobicity, Lipophilicity 展开更多
关键词 SHOW Studies on Solid-Liquid phase Transfer Equilibrium of Onium Salts
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Elastocaloric Effect in PbTiO3 Thin Films with 180°Domain Structure:A Phase Field Study
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作者 王芳 李波 +2 位作者 欧云 刘龙飞 王伟 《Chinese Physics Letters》 SCIE CAS CSCD 2018年第3期89-92,共4页
The elastocalorie effect of PbTiO3 thin films with 180° domain structure is studied using the phase field method. The influence of external stress σ33, misfit strain μm and domain wall energy on the adiabatic t... The elastocalorie effect of PbTiO3 thin films with 180° domain structure is studied using the phase field method. The influence of external stress σ33, misfit strain μm and domain wall energy on the adiabatic temperature change ( △ Tσ) at room temperature are carried out. The calculation results indicate that |△Tσ| increases as |σ33| or |μm| increases. The largest △ Tσ wlue of--7.81( is obtained at σ33 = 2 GPa and Um =-0.02. Furthermore, the domain switching behaviors under different gradient coeffcients are different, and finally affect the elastocaloric effect in PTO thin films. These results could provide a guide to choose the substrate and the preparation process in experiments. 展开更多
关键词 PTO A phase Field study Domain Structure Elastocaloric Effect in PbTiO3 Thin Films with 180
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Studies on Synthesis of Stationary Phase Containing Nicotinamide Adenine Dinucleotide(NAD) Bonded to Phospholipid-Coated Aminated Silica for HPLC
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作者 Jin Mao YOU Zong Qin RUAN Jing Wu KANG (Lanzhou Institute of Chemical Physics, Chinese Academy of Sciences, 730000) 《Chinese Chemical Letters》 SCIE CAS CSCD 1997年第3期243-246,共4页
Recently biospecific affinity chromatography has been widely used for the separation and purification of various enzymes and nucleic acids. In this paper, a series of synthetic reactions of solid-liquid phase were car... Recently biospecific affinity chromatography has been widely used for the separation and purification of various enzymes and nucleic acids. In this paper, a series of synthetic reactions of solid-liquid phase were carried out on silica surface, using a macroporous(30 mu m), microspherical silica (8 mu m) as the matrix and gamma-aminopropyltriethoxysilane as the activating agent, the nicotinamide adenine dinucleotide(NAD) was bonded through its amino groups to the carboxylic groups of linked phospholipid which was bonded covalently on aminated support. The bonded stationary phase has high thermal stability, and could be used to separate of nucleotides with good resolution. 展开更多
关键词 NAD Bonded to Phospholipid-Coated Aminated Silica for HPLC Studies on Synthesis of Stationary phase Containing Nicotinamide Adenine Dinucleotide
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