检索结果-南通市图书馆

Factors associated with success of telaprevir-and boceprevir-based triple therapy for hepatitis C virus infection

World Journal of Hepatology 2017年第11期9卷 551-561页

作者： Kian Bichoupan Neeta Tandon Valerie Martel-Laferriere Neal M Patel David Sachs Michel Ng Emily A Schonfeld Alexis Pappas James Crismale Alicia Stivala Viktoriya Khaitova Donald Gardenier Michael Linderman William Olson Ponni V Perumalswami Thomas D Schiano Joseph A Odin Lawrence U Liu Douglas T Dieterich Andrea D Branch Division of Liver Diseases Icahn School of Medicine at Mount Sinai Icahn Medical Instititute janssen pharmaceuticals Com-panies Division of Janssen Scientific Affairs Inc. Genetics and Genomics Icahn School of Medicine at Mount Sinai

To evaluate new therapies for hepatitis C virus (HCV), data about real-world outcomes are needed. METHODSOutcomes of 223 patients with genotype 1 HCV who started telaprevir- or boceprevir-based triple therapy (May 2011-March 2012) at the Mount Sinai Medical Center were analyzed. Human immunodeficiency virus-positive patients and patients who received a liver transplant were excluded. Factors associated with sustained virological response (SVR24) and relapse were analyzed by univariable and multivariable logistic regression as well as classification and regression trees. Fast virological response (FVR) was defined as undetectable HCV RNA at week-4 (telaprevir) or week-8 (boceprevir). RESULTSThe median age was 57 years, 18% were black, 44% had advanced fibrosis/cirrhosis (FIB-4 ≥ 3.25). Only 42% (94/223) of patients achieved SVR24 on an intention-to-treat basis. In a model that included platelets, SVR24 was associated with white race [odds ratio (OR) = 5.92, 95% confidence interval (CI): 2.34-14.96], HCV sub-genotype 1b (OR = 2.81, 95%CI: 1.45-5.44), platelet count (OR = 1.10, per x 104 cells/μL, 95%CI: 1.05-1.16), and IL28B CC genotype (OR = 3.54, 95%CI: 1.19-10.53). Platelet counts > 135 x 103/μL were the strongest predictor of SVR by classification and regression tree. Relapse occurred in 25% (27/104) of patients with an end-of-treatment response and was associated with non-FVR (OR = 4.77, 95%CI: 1.68-13.56), HCV sub-genotype 1a (OR = 5.20; 95%CI: 1.40-18.97), and FIB-4 ≥ 3.25 (OR = 2.77; 95%CI: 1.07-7.22). CONCLUSIONThe SVR rate was 42% with telaprevir- or boceprevir-based triple therapy in real-world practice. Low platelets and advanced fibrosis were associated with treatment failure and relapse.

关键词： Sustained virologic response Hepatitis C virus Relapse Telaprevir Boceprevir Triple-therapy Classification and regression Adverse event Real-world

来源：

维普期刊数据库评论

在线全文

维普期刊数据库

学校读者我要写书评

暂无评论

Novel genomic biomarkers for acute gentamicin nephrotoxicity in dog

引用

Open Journal of Molecular and Integrative Physiology 2013年第3期3卷 125-133页

作者： James Eric McDuffie Jingjin Gao Jingying Ma David La Anton Bittner Manisha Sonee Matthew Wagoner Sandra Snook CREATe-Genomic Technologies Janssen Pharmaceutical Research & Development LLC San Diego USA Drug Safety Sciences Janssen Pharmaceutical Research & Development LLC San Diego USA Drug Safety Sciences Janssen Pharmaceutical Research & Development LLC Spring House USA Safety Assessment AstraZeneca Pharmaceuticals Watham USA

Objectives: Novel biomarkers indicative of drug-induced kidney injury (DIKI) in dogs would have significant application in preclinical drug development. We conducted a feasibility study to identify genomic expression profiles for monitoring progressive, acute DIKI in dogs. Materials and Methods: Animals were intramuscularly administered either 0.9% physiological saline or gentamicin (40 mg/kg/day) for 10 consecutive days and euthanized on day 11. Serum and urine samples were collected at various time points and kidney samples were collected at necropsy for biomarker measurements. Results: Acute gentamicin-induced renal histopathology changes were localized to the proximal convoluted tubules and characterized as slight-to-marked, diffuse cortical-medullary tubular epithelial degeneration/necrosis. Serum creatinine (sCr) and blood urea nitrogen (BUN) elevations suggestive of mild renal dysfunction were first observed on days 7 to 8. Gentamicin-induced increased urinary kidney injury molecule-1 (KIM-1) mRNA was observed on day 6 preceding detectable elevations of sCr and/or BUN. Increased urinary KIM-1 mRNA correlated with multifocal KIM-1 immunostaining in the corticomedullary tubular epithelial cells. Microarray analysis revealed changes in additional mRNA expression products detected in urine and/or kidney that should be further investigated for use as potential biomarkers for acute gentamicin related nephrotoxicity in dogs. Conclusion: These findings suggested the utility of non-invasive urinary genomic parameters for monitoring acute DIKI in dogs.

关键词： Biomarker Gentamicin Nephrotoxicity Dog

来源：

维普期刊数据库评论

在线全文

维普期刊数据库

学校读者我要写书评

暂无评论

Breakthrough cancer medicine and its impact on novel drug development in China: report of the US Chinese Anti-Cancer Association (USCACA) and Chinese Society of Clinical Oncology (CSCO) Joint Session at the 17th CSCO Annual Meeting

引用

Chinese Journal of Cancer 2014年第12期33卷 620-624页

作者： Feng Roger Luo Jian Ding Helen X. Chen Hao Liu Man-Cheong Fung Maria Koehler Jean Pierre Armand Lei Jiang Xiao Xu Ge Zhang Li Xu Pascal Qian Li Yan The US Chinese Anti-Cancer Association MartinezCA 94553 USA Department of Oncology Janssen Research & Development LLC RaritanNJ 08869 USA Shanghai Institute of Materia Medica Chinese Academy of Sciences Cancer Therapy Evaluation Program National Cancer Institute Novartis pharmaceuticals (China) Oncology Pfizer Oncology New YorkNY 10017 USA Institut Gustave Roussy Cancer Campus Grand Paris ACEA Biosciences Inc. Jiangsu Hengrui Medicine Co. Ltd. Beijing Cancer Hospital and Institute Peking University School of Oncology

The US Chinese Anti-Cancer Association(USCACA)teamed up with Chinese Society of Clinical Oncology(CSCO)to host a joint session at the17th CSCO Annual Meeting on September 20th,2014in Xiamen,*** a focus on breakthrough cancer medicines,the session featured innovative approaches to evaluate breakthrough agents and established a platform to interactively share successful experiences from case studies of 6 novel agents from both the United States and *** goal of the session is to inspire scientific and practical considerations for clinical trial design and strategy to expedite cancer drug development in China.A panel discussion further provided in-depth advice on advancing both early and full development of novel cancer medicines in China.

关键词：抗癌药物中国临床美国学会肿瘤协会新药

来源：

维普期刊数据库

同方期刊数据库评论

在线全文

学校读者我要写书评

暂无评论

SARS-CoV-2 variants:A continuing threat to global health

引用

Asian Pacific Journal of Tropical Medicine 2022年第1期15卷 1-3页

作者： Balamurugan Shanmugaraj Narach Khorattanakulchai Waranyoo Phoolcharoen Baiya Phytopharm Co. LtdBangkok10250Thailand Research Unit for Plant-produced pharmaceuticals Chulalongkorn UniversityBangkok10330Thailand Department of Pharmacognosy and Pharmaceutical Botany Faculty of Pharmaceutical SciencesChulalongkorn UniversityBangkok10330Thailand

Coronavirus disease 2019(COVID-19)is an acute respiratory illness caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2).COVID-19 pandemic has an unprecedented impact on economy,trade and human lifestyle *** the emergence of of SARS-CoV-2,more than 266 million infections and 5260888 deaths were reported globally over the last two years[1].The scientific achievements particularly in last two years yielded effective vaccines against COVID-19.A variety of platform technologies including protein subunit,viral vector,RNA,inactivated and DNA are being employed to develop effective *** date,vaccines that have been approved against COVID-19 include the Pfizer BioNTech(mRNA vaccine),Oxford-AstraZeneca(viral vector vaccine),Moderna(mRNA vaccine),janssen ***2.S(viral vector),Sinopharm,Sinovac-CoronaVac,Bharat Biotech’s Covaxin(inactivated virus vaccines),*** of December 2021,over 8 billion doses of COVID-19 vaccines have been administered globally[1].The details on the number of COVID-19 confirmed cases and global vaccination coverage are provided in Figure 1.

关键词： Pfizer doses globally

来源：

维普期刊数据库评论

在线全文

维普期刊数据库

学校读者我要写书评

暂无评论

The Need of Industry to Go FAIR

引用

Data Intelligence 2020年第1期2卷 276-284,320,321,322页

作者： Herman van Vlijmen Albert Mons Arne Waalkens Wouter Franke Arie Baak Gerbrand Ruiter Christine Kirkpatrick Luiz Olavo Bonino da Silva Santos Bert Meerman Renger Jellema Derk Arts Martijn Kersloot Sebastiaan Knijnenburg Scott Lusher Rudi Verbeeck Jean-Marc Neefs janssen pharmaceuticals Antwerpseweg 152340 BeerseBelgium Phortos Consultants The Netherlands Accenture Gustav Mahlerplein 901082 MA AmsterdamThe Netherlands Zorg Instituut Nederland Willem Dudokhof 11112 ZA DiemenThe Netherlands Euretos Yalelaan 13584 CL UtrechtThe Netherlands Mobiquity Tommaso Albinonistraat 91083 HM AmsterdamThe Netherlands UCSD and National Data Service 10100 Hopkins DrLa JollaCA 92093USA GO FAIR International Support&Coordination Office(GFISCO) LeidenThe Netherlands GO FAIR Foundation Rijnsburgerweg 102333 AA LeidenThe Netherlands DSM Biotechnology Center Alexander Fleminglaan 12613 AX DelftThe Netherlands Castor Paasheuvelweg 25Vleugel 5D1105 BP AmsterdamThe Netherlands

The industry sector is a very large producer and consumer of data,and many companies traditionally focused on production or manufacturing are now relying on the analysis of large amounts of data to develop new products and *** many of the data sources needed are distributed and outside the company,FAIR data will have a major impact,both by reducing the existing internal data silos and by enabling the efficient integration with external(public and commercial)*** companies are still in the early phases of internal data”FAIRification”,providing opportunities for SMEs and academics to apply and develop their expertise on FAIR data in collaborations and public-private *** a global Internet of FAIR Data&Services to thrive,also involving industry,professional tools and services are *** metrics and certifications on individuals,data,organizations,and software,must ensure that data producers and consumers have independent quality metrics on their *** this opinion article we reflect on some industry specific challenges of FAIR implementation to be dealt with when choices are made regarding”Industry GOing FAIR”.

关键词： FAIR application

来源：

维普期刊数据库

同方期刊数据库评论

在线全文

学校读者我要写书评

暂无评论

Control strategy and methods for continuous direct compression processes

引用

Asian Journal of Pharmaceutical Sciences 2021年第2期16卷 253-262页

作者： Yasuhiro Suzuki Hirokazu Sugiyama Manabu Kano Ryutaro Shimono Gosuke Shimada Ryoichi Furukawa Eichi Mano Keiichi Motoyama Tatsuo Koide Yasuhiro Matsui Kazuki Kurasaki Issei Takayama Shunin Hikage Noriko Katori Masahiko Kikuchi Hiroshi Sakai Yoshihiro Matsuda Formulation Technology Research Laboratories Daiichi Sankyo Co.Ltd.Kanagawa 254-0014Japan Department of Chemical System Engineering The University of TokyoTokyo 113-8656Japan Department of Systems Science Kyoto UniversityKyoto 606-8501Japan CMC Sciences Department Regulatory Affairs DivisionR&D DivisionJanssen Pharmaceutical K.K.Tokyo 101-0065Japan EuroTechno Ltd. Kanagawa 223-0057Japan Pharmaceutical Research Department Mitsubishi Tanabe Pharma CorporationOsaka 532-8505Japan Chemical Products CMC Regulatory Affairs Area Japan DevelopmentMSD K.K.Tokyo 102-8667Japan Graduate School of Pharmaceutical Sciences Kumamoto UniversityKumamoto 862-0973Japan Division of Drugs National Institute of Health SciencesKawasaki 210-9501Japan Technology Research&Development Sumitomo Dainippon Pharma Co.Ltd.Osaka 564-0053Japan Formulation Development Department Chugai pharmaceutical Co.Ltd.Tokyo 115-8543Japan Office of New Drug IV Pharmaceuticals and Medical Devices AgencyShin-Kasumigaseki Bldg.Tokyo 100-0013Japan Office of Generic Drugs Pharmaceuticals and Medical Devices AgencyShin-Kasumigaseki Bldg.Tokyo 100-0013Japan KOKANDO Co. Ltd.Toyama 930-8580Japan pharmaceuticals and Medical Devices Agency Shin-Kasumigaseki Bldg.Tokyo 100-0013Japan

We presented a control strategy for tablet manufacturing processes based on continuous direct *** work was conducted by the experts of pharmaceutical companies,machine suppliers,academia,and regulatory authority in *** different items in the process,the component ratio and blended powder content were selected as the items requiring the control method specific to continuous manufacturing different from the conventional batch *** control and management of the Loss in Weight(LIW)feeder were deemed the most important,and the Residence Time Distribution(RTD)model were regarded effective for setting the control range and for controlling of the LIW *** on these ideas,the concept of process control using RTD was summarized.

关键词： Continuous manufacturing Solid drug products Process control Residence time distribution Loss in weight feeder Regulatory science

来源：

维普期刊数据库

同方期刊数据库评论

在线全文

学校读者我要写书评

暂无评论

A Controlled Study on the Effect of Preoperative Nutritional Assessment and Intervention on the Clinical Efficacy of Patients with Esophageal Cancer

引用

Advances in Modern Oncology Research 2019年第6期5卷 15-19页

作者： Jaeho Cho Dr Sc Hum Department of Cardiovascular and Metabolism-Medical Affairs Janssen Pharmaceuticals Inc.New JerseyUSA Former Director General of Agricultural Research System Pakistan

The purpose of this study was to analyze the effect of preoperative nutritional assessment and intervention on the clinical efficacy of patients with esophageal ***,110 patients with esophageal cancer admitted to our hospital from December 2014 to December 2016 were selected,including 78 males and 27 female were randomly selected as the observation group and control *** the observation group,26 cases received nutritional support,22 cases did not receive nutritional support,15 cases in the control group,47 cases did not receive nutritional *** non-protein calories were no less than 41.8kj•kg-1•***(PAB),transferrin(TRF)and albumin(ALB)were tested before,1 and 5 days after ***,IgG and IgM were detected by immunosuspension *** cytometry was used to detect CD3 and *** incidence of postoperative complications(incision infection,pulmonary infection,anastomotic fistula,chylothorax,bleeding,esophagotracheal fistula,cardiovascular complications,and digestive tract diseases)was *** results showed that 48 patients(43.64%)in the observation group had nutritional risk(≥3 points),while 62 patients(56.36%)in the control group had no nutritional risk(0.05)postoperative indicators showed that all indicators continued to *** level of immune factors in the nutrition support group was higher than 1 day before surgery and close to the preoperative *** indicated that effective preoperative nutritional support for esophageal cancer patients with nutritional risk can inhibit the decomposition of immunoglobulin,which is conducive to the recovery of postoperative immune function and improve the tolerance of the body to comprehensive tumor *** the sam

关键词： Esophageal cancer Nutritional support Complications

来源：

维普期刊数据库评论

在线全文

维普期刊数据库

学校读者我要写书评

暂无评论

Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome

引用

四川生理科学杂志 2023年第10期45卷 1848-1848页

作者： Gregory G Schwartz From the Division of Cardiology University of Colorado School of Medicine Aurora (G.G.S.) Assistance Publique–Hôpitaux de Paris Hôpital Bichat Paris Diderot University Sorbonne Paris Cité FACT (French Alliance for Cardiovascular Trials) and INSERM Unité 1148 (P.G.S.) and Sanofi (C.H. G.L.) — all in Paris the National Heart and Lung Institute Imperial College Royal Brompton Hospital London (P.G.S.) the State University of New York Downstate School of Public Health Brooklyn (M.S.) and Regeneron Pharmaceuticals Tarrytown (R.P. W.J.S.) — both in New York Brigham and Women’s Hospital Heart and Vascular Center and Harvard Medical School Boston (D.L.B.) the Division of Cardiovascular Disease University of Alabama at Birmingham Birmingham (V.A.B.) Estudios Cardiológicos Latinoamérica Instituto Cardiovascular de Rosario Rosario Argentina (R.D.) Sanofi Bridgewater NJ (J.M.E. A.M. J.-F.T.) the Canadian VIGOUR Centre University of Alberta Edmonton and St. Michael’s Hospital University of Toronto Toronto — both in Canada (S.G.G.) Stanford Center for Clinical Research Department of Medicine Stanford University Stanford CA (R.A.H. K.W.M.) the Department of Cardiology Leiden University Medical Center Leiden the Netherlands (J.W.J.) Duke Clinical Research Institute Duke University Medical Center (K.Q. M.T.R. P.T.) and the Division of Cardiology Department of Medicine Duke University School of Medicine (M.T.R.) Durham NC Green Lane Cardiovascular Services Auckland City Hospital Auckland New Zealand (H.D.W.) and the Department of Medicine III Goethe University Frankfurt am Main Germany (A.M.Z.).

Background:Patients who have had an acute coronary syndrome are at high risk for recurrent ischemic cardiovascular *** sought to determine whether alirocumab,a human monoclonal antibody to proprotein convertase subtilisin-kexin type 9(PCSK9),would improve cardiovascular outcomes after an acute coronary syndrome in patients receiving high-intensity statin therapy.

关键词： cardiovascular acute coronary

来源：

维普期刊数据库评论

在线全文

维普期刊数据库

学校读者我要写书评

暂无评论

欢迎您,

建议与咨询留下您的常用邮箱和电话号码，以便我们向您反馈解决方案和替代方法

时间限定

文献类型

馆藏选择

核心期刊

语言

文献类型

帮助

文字说明：

检索规则说明：

检索范例：

分类表

所选分类

限定检索结果

文献类型

馆藏范围

日期分布

学科分类号

主题

机构

作者

语言

在线全文

在线全文

在线全文

在线全文

在线全文

在线全文

在线全文

在线全文

请选择保存的检索档案：

请选择收藏分类：

通借通还

欢迎您,

建议与咨询 留下您的常用邮箱和电话号码，以便我们向您反馈解决方案和替代方法

时间限定

文献类型

馆藏选择

核心期刊

语言

文献类型

帮助

文字说明：

检索规则说明：

检索范例：

分类表

所选分类

限定检索结果

文献类型

馆藏范围

日期分布

学科分类号

主题

机构

作者

语言

在线全文

在线全文

在线全文

在线全文

在线全文

在线全文

在线全文

在线全文

请选择保存的检索档案： 新增检索档案 确定 取消

请选择收藏分类： 新增自定义分类 确定 取消

通借通还

建议与咨询留下您的常用邮箱和电话号码，以便我们向您反馈解决方案和替代方法

请选择保存的检索档案：

请选择收藏分类：