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本文旨在遵从药品注册技术要求一致化的原则下,对人用药品注册技术要求国际协调会议(ICH)所倡导执行的通用技术文件(CTD)进行比较全面的阐述和理解,详细介绍CTD在ICH6上的进展情况,就美国食品药品监督管理局对CTD的实施过程予以简介和研究,并深入探讨其对于我国药品注册规范等方面的影响和启示。 相似文献
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《Journal of the American College of Radiology》2015,12(3):228-234
The current initiative to reform health care from both a quality and a cost perspective has already had a profound impact on the radiology enterprise. We have seen a decrease in the utilization of imaging studies, a reduction in reimbursement, a declining payer mix, shrinking incomes, a proliferation of performance indices, creation of radiology mega-groups, growth of national radiology companies, and increasing turf incursions. Our cheese is clearly on the move, and we must take action to reengineer the radiology enterprise. In keeping with general health care reform, we must be patient-centric, data driven, and outcome based. We must create a radiology enterprise that adheres to the value equation of providing the highest quality health care, for the lowest possible cost, for all citizens. 相似文献
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唐健雄|李绍杰 《中国普通外科杂志》2016,25(10):1377-1380
第九届全国疝和腹壁外科学术大会于2016年7月7日—7月9日在广东省广州市举行,笔者就大会的主要内容进行归纳和总结,并对我国疝外科的现状与发展趋势进行分析,认为疝外科的发展离不开术式的规范化、标准化以及新材料的应用,更离不开学术争鸣和交流。相信此次会议将为我国疝外科的临床诊疗水平的提高以及科研的进步提供积极的作用。 相似文献
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Shilpa N. Naik Ajay Chandanwale Dileep Kadam P.W. Sambarey Gauri Dhumal Andrea DeLuca Divyashri Jain Amita Gupta Robert Bollinger Vidya Mave 《The Indian journal of tuberculosis》2021,68(1):85-91
BackgroundDiagnosis of genital tuberculosis (TB) as a cause of infertility still remains a diagnostic dilemma for clinicians, as no standard guidelines exist. The recently proposed best practices for genital TB diagnosis have not been evaluated yet in India.ObjectivesTo implement best practices to diagnose and treat likely genital TB as a cause of infertility.MethodsBetween April 2016 and June 2018, consenting women seen at a tertiary hospital infertility clinic were assessed by thorough TB related clinical history, ultrasonography, tuberculin skin test (TST), and ESR. Those with suspected genital TB underwent laparohysteroscopy. Clinical and laboratory characteristics were compared between likely (microbiologically confirmed or probable TB) and unlikely (possible and no genital TB) genital TB. Fertility outcome was assessed among women initiated on anti-TB treatment (ATT).ResultsOf 185 women seeking infertility care, likely genital TB was identified among 29 (15.7%) women, with 6 (21%) confirmed and 23 (79%) probable genital TB. Compared to unlikely genital TB cases, the likely genital TB group were found to have past history of TB (p < 0.001); positive TST (p = 0.002) and elevated ESR (p = 0.001). Among the likely genital TB group, all 6 confirmed genital TB were started on ATT and 2 (33.3%) conceived. Of 5 probable genital TB started on ATT, 3 (60%) conceived.ConclusionApproximately 1/6th of women seeking infertility care met the criteria for likely genital TB. Conception among over-half of treated probable genital TB cases provides preliminary evidence that best clinical practices can be utilized, but needs further confirmatory studies. 相似文献
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