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| 1 | 美国仿制药行业发展头25年的经验教训显示文摘本文回顾了自《1984年药品价格竞争与专利期补偿法案》实施、创立美国仿制药行业以来,美国仿制药行业的发展经验和教训。对仿制药丑闻、仿制药审批制度发展、生物等效性与可替代性、复杂剂型的生物等效性方法、专利常青、授权仿制药、仿制药安全性、仿制药审评、仿制药替代、4美元仿制药等美国仿制药行业发展中的关键性事件和过程进行了系统回顾与分析。美国仿制药行业在头25年发展历程中的经验教训,对其他希望建立或重新建立国内仿制药行业的国家有借鉴作用。 | Garth Boehm 姚立新 韩亮 郑强 | 2012 | 中国新药杂志2012，21，16： | 22 |
| 2 | 美国药品短缺及FDA采取的应对策略显示文摘根据FDA报告、美国国会报告和《2012年FDA安全与创新法案》分析归纳近年来美国出现的药品短缺及原因,以及药品监管机构采取的针对性措施和效果。药品短缺问题的解决不能诉诸于单一、简单的解决方案,而是需要监管机构、药品生产商、经销商、医疗保健服务提供商和其他利益攸关者的协作。 | 姚立新 Garth Boehm 郑强 | 2012 | 中国新药杂志2012，21，20： | 12 |
| 3 | 世界家庭医生组织对全球家庭医学的推进和发展倡议显示文摘2016年3月,由《中国全科医学》杂志社承办的第三届海峡两岸全科医学大会暨海峡两岸医药卫生交流协会全科医学专业委员会第三届学术年会在深圳隆重召开,会议主题为“提升全科医疗质量、促进健康中国建设”。此次大会云集了世界各国的专家、教授,在全科医学的发展和学术成果展示方面进行了深刻的探讨。GaahManning是初级保健护理发展、教育改革、培训项目开发与交付、家庭医学组织发展方面的资深国际顾问,自2012年10月担任世界家庭医生组织(WONCA)的首席执行官至今,在WONCA和全球家庭医学事业的发展中功不可没。本期重点报道了GaahManning在大会上的演讲内容,主题为“世界家庭医生组织对全球家庭医学的推进和发展倡议”,敬请关注! | Garth Mannnig | 2016 | 中国全科医学2016，19，16： | 8 |
| 4 | Mesenchymal stem cell-mediated cancer therapy: A dualtargeted strategy of personalized medicine显示文摘Cancer remains one of the leading causes of mortal-ity and morbidity throughout the world. To a signifi-cant extent, current conventional cancer therapies are symptomatic and passive in nature. The major obstacle to the development of effective cancer therapy is be-lieved to be the absence of suffi cient specifi city. Since the discovery of the tumor-oriented homing capacity of mesenchymal stem cells (MSCs), the application of specific anticancer gene-engineered MSCs has held great potential for cancer therapies. The dual-targeted strategy is based on MSCs’ capacity of tumor-directed migration and incorporation and in situ expression of tumor-specifi c anticancer genes. With the aim of trans-lating bench work into meaningful clinical applications, we describe the tumor tropism of MSCs and their use as therapeutic vehicles, the dual-targeted anticancer potential of engineered MSCs and a putative personal-ized strategy with anticancer gene-engineered MSCs. | Garth L Warnock | 2011 | World Journal of Stem Cells2011，3，11： | 7 |
| 5 | Screening pre-bariatric surgery patients for esophageal disease with esophageal capsule endoscopy显示文摘AIM:To determine if esophageal capsule endoscopy(ECE)is an adequate diagnostic alternative to esophagogastroduodenoscopy(EGD)in pre-bariatric surgery patients.METHODS:We conducted a prospective pilot study to assess the diagnostic accuracy of ECE(PillCam ESO2,Given Imaging)vs conventional EGD in pre-bariatric surgery patients.Patients who were scheduled for bariatric surgery and referred for pre-operative EGD were prospectively enrolled.All patients underwent ECE followed by standard EGD.Two experienced gastroenterologists blinded to the patient’s history and the findings of the EGD reviewed the ECE and documented their findings.The gold standard was the findings on EGD.RESULTS:Ten patients with an average body mass index of 50 kg/m2were enrolled and completed the study.ECE identified 11 of 14(79%)positive esophageal/gastroesophageal junction(GEJ)findings and 14of 17(82%)combined esophageal and gastric findings identified on EGD.Fisher’s exact test was used to compare the findings and no significant difference was found between ECE and EGD(P=0.64 for esophageal/GEJ and P=0.66 for combined esophageal and gastric findings respectively).Of the positive esophageal/GEJ findings,ECE failed to identify the following:hiatal hernia in two patients,mild esophagitis in two patients,and mild Schatzki ring in two patients.ECE was able to identify the entire esophagus in 100%,gastric cardia in0%,gastric body in 100%,gastric antrum in 70%,pylorus in 60%,and duodenum in 0%.CONCLUSION:There were no significant differences in the likelihood of identifying a positive finding using ECE compared with EGD in preoperative evaluation of bariatric patients. | Ashish Shah Erica Boettcher Marianne Fahmy Thomas Savides Santiago Horgan Garth R Jacobsen Bryan J Sandler Michael Sedrak Denise Kalmaz | 2013 | World Journal of Gastroenterology2013，19，37： | 7 |
| 6 | In Vivo Therapeutic Silencing of Hypoxia-Inducible Factor 1 Alpha(HIF-1)Using Single-Walled Carbon Nanotubes Noncovalently Coated with siRNA显示文摘A new approach is described for delivering small interfering RNA(siRNA)into cancer cells by noncovalently complexing unmodifi ed siRNA with pristine single-walled carbon nanotubes(SWCNTs).The complexes were prepared by simple sonication of pristine SWCNTs in a solution of siRNA,which then served both as the cargo and as the suspending agent for the SWCNTs.When complexes containing siRNA targeted to hypoxia-inducible factor 1 alpha(HIF-1)were added to cells growing in serum containing culture media,there was strong specific inhibition of cellular HIF-1 activity.The ability to obtain a biological response to SWCNT/siRNA complexes was seen in a wide variety of cancer cell types.Moreover,intratumoral administration of SWCNT-HIF-1 siRNA complexes in mice bearing MiaPaCa-2/HRE tumors signifi cantly inhibited the activity of tumor HIF-1.As elevated levels of HIF-1 are found in many human cancers and are associated with resistance to therapy and decreased patient survival,these results imply that SWCNT/siRNA complexes may have value as therapeutic agents. | Geoffrey Bartholomeusz Paul Cherukuri John Kingston Laurent Cognet Robert Lemos Jr Tonya KLeeuw Laura Gumbiner-Russo RBruce Weisman Garth Powis | 2009 | Nano Research2009，2，4： | 7 |
| 7 | 企业付费法案与仿制药产业发展显示文摘目的:研究美国FDA如何借助企业付费的方法来应对药品生产、供应全球化和不断增长的工作量的挑战,以便提高药品可及性和缓解药品短缺。方法:根据美国FDA、国会和政府问责办公室的资料及业界报告等,分析企业付费对保证药品安全性、可及性和监管机构透明度方面的作用。结果:采取公开、整体性的企业付费方式,有助于加速仿制药审评、实现海内外生产设施检查频率一致、保障药品的可及性和安全性及增加监管透明度。结论:仿制药企业付费法案对推动政企合作,合理利用企业资源,解决监管机构、产业界和利益攸关方共同面对的棘手问题,推动全球化时代药品监管方式的转变,提供了一条可行的途径。 | Garth Boehm 姚立新 郑强 | 2013 | 中国新药杂志2013，22，2： | 6 |
| 8 | Anemia and iron deficiency in gastrointestinal and liver conditions显示文摘Iron deficiency anemia(IDA) is associated with a number of pathological gastrointestinal conditions other than inflammatory bowel disease, and also with liver disorders. Different factors such as chronic bleeding, malabsorption and inflammation may contribute to IDA. Although patients with symptoms of anemia are frequently referred to gastroenterologists, the approach to diagnosis and selection of treatment as well as follow-up measures is not standardized and suboptimal. Iron deficiency, even without anemia, can substantially impact physical and cognitive function and reduce quality of life. Therefore, regular iron status assessment and awareness of the clinical consequences of impaired iron status are critical. While the range of options for treatment of IDA is increasing due to the availability of effective and well-tolerated parenteral iron preparations, a comprehensive overview of IDA and its therapy in patients with gastrointestinal conditions is currently lacking. Furthermore, definitions and assessment of iron status lack harmonization and there is a paucity of expert guidelines on this topic. This review summarizes current thinking concerning IDA as a common co-morbidity in specific gastrointestinal and liver disorders, and thus encourages a more unified treatment approach to anemia and iron deficiency, while offering gastroenterologists guidance on treatment options for IDA in everyday clinical practice. | Jürgen Stein Susan Connor Garth Virgin David Eng Hui Ong Lisandro Pereyra | 2016 | World Journal of Gastroenterology2016，22，35： | 5 |
| 9 | Natural orifice surgery: initial clinical experience显示文摘 | Santiago Horgan John P. Cullen Mark A. Talamini Yoav Mintz Alberto Ferreres Garth R. Jacobsen Bryan Sandler Julie Bosia Thomas Savides David W. Easter Michelle K. Savu Sonia L. Ramamoorthy Emily Whitcomb Sanjay Agarwal Emily Lukacz Guillermo Dominguez Ped | 2009 | Surgical Endoscopy2009，，7： | 5 |
| 10 | Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984显示文摘The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed,including the process of approval for generic drugs,bioequivalence issues including“switchability”,bioequivalence for complicated dosage forms,patent extension,generic drug safety,generic substitution and low-cost generics.The backlog in generic review,generic drug user fees,and“quality by design”for generic drugs is also discussed.The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry. | Garth Boehm Lixin Yao Liang Han Qiang Zheng | 2013 | Acta Pharmaceutica Sinica B2013，3，5： | 4 |
| 11 | 指南 成人原发及转移性脑肿瘤:NICE指南概要显示文摘原发恶性脑肿瘤虽然仅占癌症总数的3%,但其生存预后在所有癌症中却是最差的。尽管诊治水平有所改善,但恶性脑肿瘤的存活率依然很低(表1);人们认为通过制定全国统一实行的规范化指南,可延长患者寿命并改善生活质量。超过60%原发性脑肿瘤患者的初次诊断不是由全科医生或专科医生做出的,而是偶然发现的,或是在急诊就诊中发现的。在初级医疗中,最常见的脑肿瘤是脑转移瘤,当然也有其他类型脑肿瘤。 | Alex Bates Garth Cruickshank Tom Roques Guideline Committee 徐菲(译) 王燕(校) | 2018 | 英国医学杂志中文版2018，21，11： | 3 |
| 12 | FDA公布2014财年仿制药企业付费修正案(GDUFA)付费标准显示文摘FDA公布2014财年仿制药企业付费细则。根据通货膨胀指数调整后,2014财年仿制药企业付费总额为$305 659 000,各项付费标准分别为:仿制药申请$63 860,批准前补充申请$31 930,主文件$31 460,美国境内制剂设施$220 152,美国境外制剂设施$235 152,美国境内原料药设施$34 515,美国境外原料药设施$49 515。由于部分仿制药企业退出,各项付费额比前一财年显著增加。预期后继财年付费将会继续增长,但对仿制药行业的发展的影响并不明了。 | Garth Boehm 姚立新 郑强 | 2013 | 中国新药杂志2013，22，18： | 2 |
| 13 | Hepatitis B vaccination in patients with inflammatory bowel disease显示文摘AIM:To determine the prevalence for hepatitis B virus(HBV) and HBV screening and vaccination practices for inflammatory bowel disease(IBD).METHODS:This study is a retrospective,cross-sectional observational study.A retrospective chart review was performed in 500 patients who have been consecutively treated for IBD between September 2008 and January 2013 at the Rush University Medical Center Gastroenterology section.The patients were identified through the electronic medical record with the criteria that they attended the gastroenterology clinic,and that they had a diagnosis of IBD at the time of visit discharge.Once identified,each record was analyzed to determine whether the subject had been infected with HBV in the past,already been vaccinated against HBV,or advised to get vaccinated and followed through with the recommended vaccination.RESULTS:About 254 out of 500 patients(51%) had HBV screening ordered.Among those ordered to have screening tests,86% followed through with HBV serology.Gastroenterology physicians had significantly different screening ratios from each other(P < 0.001).There were no significant differences in the ratios of HBV screening when IBD specialists were compared to other gastroenterology physicians(0.505 ± 0.023 vs 0.536 ± 0.066,P = 0.66).Of those 220 patients screened,51% of IBD patients were found not to be immune against HBV.Approximately 50% of gastroenterology physicians recommended HBV vaccinations to their patients in whom serology was negative for antibodies against HBV.IBD specialists recommended vaccinations to a higher percentage of their patients compared to other gastroenterology physicians(0.168 ± 0.019 vs 0.038 ± 0.026,P = 0.015).Present and/or past HBV infection was found in 3.6% of the patients who had serology checked.There was no statistically significant difference in the prevalence of hepatitis B surface antigen(HBsAg) between our study and that reported in previous studies done in Spain(4/220 vs 14/2076 respectively,P = 0.070); and in France(4/220 vs 3/315 respectively,P = 0.159).But,the prevalence of anti-HBcAb in this study was less than that reported in the study in Spain(7/220 vs 155/2076 respectively,P = 0.006); and was not sig-nificantly different from that reported in the study in France(7/220 vs 8/315 respectively,P = 0.313).CONCLUSION:The prevalence of HBsAg in our IBD patients was not higher than previously reported European studies.Most IBD patients are not routinely screened or vaccinated against HBV at a tertiary referral center in the United States. | Ruwaida Ben Musa Anuhya Gampa Sanjib Basu Ali Keshavarzian Garth Swanson Michael Brown Rana Abraham Keith Bruninga John Losurdo Mark DeMeo Sohrab Mobarhan David Shapiro Ece Mutlu | 2014 | World Journal of Gastroenterology2014，20，41： | 2 |
| 14 | Organic/inorganic hybrid network materials by the sol-gel approach 显示文摘 | WEN Jianye WILKES Garth L | 1996 | Chem Mater1996，，8： | 2 |
| 15 | Phase II Pilot Study of Vemurafenib in Patients With Metastatic BRAF -Mutated Colorectal Cancer显示文摘 | Kopetz Scott Desai Jayesh Chan Emily Hecht Joel Randolph O’Dwyer Peter J. Maru Dipen Morris Van Janku Filip Dasari Arvind Chung Woonbook Issa Jean-Pierre J. Gibbs Peter James Brian Powis Garth Nolop Keith B. Bhattacharya Suman Saltz Leonard | 2015 | Journal of Clinical Oncology2015，，34： | 2 |
| 16 | 汽车零部件电磁兼容测试标准与设施要求显示文摘1概述
汽车行业电磁兼容标准主要由国际无线电干扰特别委员(CISPR),国际标准化组织(ISO)和美国汽车工程学会(SAE)等国际标准化组织主导编制。CISPR和ISO主要负责编写和维护国际标准。SAE主要负责编写和维护北美地区的标准。SAE编写的标准已有很多逐渐被CISPR和ISO采纳并使用。CISPR/D主要编写和维护由车辆或其内部零部件产生的电磁干扰测试标准。ISO/TC22/SC32/WG3负责对车辆及其内部零部件电磁抗干扰类标准的编写和维护, | Garth D'Abreu Ammar Sarwar Craig Fanning 王东 | 2016 | 安全与电磁兼容2016，，5： | 2 |
| 17 | Dynamic habitat selection by two wading bird species with divergent foraging strategies in a seasonally fluctuating wetland显示文摘 | Beerens James M Gawlik Dale E Herring Garth Cook Mark I | 2011 | EN2011，，4： | 2 |
| 18 | Repair of Bridge Girder Damaged by Impact Loads with Prestressed CFRP Sheets显示文摘 | Yail J Kim Mark F Green Garth J Fallis | 2008 | Journal of Bridge Engineering2008，13，1： | 1 |
| 19 | Delayed proximal repair and distal realignment after patellar dislocation 显示文摘 | Garth WP Dichristina DG Holt G | 2000 | Clin Orthop Relat Res2000，，377： | 1 |
| 20 | Streamline integration usingMPI-hybrid parallelism on a large multicore arctiitecture显示文摘 | Camp D Garth C Childs H | 2011 | IEEE Transactions on Visualization and Computer Graphics2011，17，11： | 1 |
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