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1.
中美两国批准仿制药情况比较分析   总被引:4,自引:0,他引:4  
严中平  陈玉文 《中国新药杂志》2007,16(21):1731-1733
采用文献检索法和统计分析方法,通过对FDA近5年批准的仿制药和我国对应产品批准数据的比较分析,得出我国仿制药在某些种类产品及新剂型、新给药系统开发上与美国仍有较大差距,尚有很大的发展空间。  相似文献
2.
国外对原研药和仿制药的临床治疗等同性评价研究进展   总被引:2,自引:0,他引:2  
张程亮  杜光 《药品评价》2010,7(20):23-27
目的:介绍国外近年来对原研药和仿制药临床治疗等同性的评价研究。方法:通过文献调研.从心血管病药物、抗抑郁药、抗感染药物,抗骨质疏松药.抗癫痫药和抗精神病药等方面进行分析总结。结果与结论:目前关于原研药和仿制药的治疗等同性方面仍然存在众多不一致的结论.系统而严格的临床研究尚需进一步开展。期望理论在评价仿制药与原研药的治疗等同性领域可发挥重要作用。临床医务人员和患者在原研药治疗过程中替换为仿制药时仍然应该十分谨慎。  相似文献
3.
孙静 《中国药房》2010,(44):4137-4139
目的:为制定和调整我国基本药物价格和采购监管政策提供参考。方法:对我国黑龙江省、马来西亚、蒙古和越南的公立药品采购系统相关政策,及其2009年5~9月31个基本药物的公立采购价格进行国家间和与国际及世界卫生组织西太平洋地区中位数价格的比较、分析。结果与结论:我国黑龙江省公立药品采购系统多数只采购国产通用名药,价格水平与健康管理科学组织(MSH)和世界卫生组织西太平洋地区相当,但与印度通用名药、甚至是品牌通用名药相比偏高。某些同时采购通用名药和原研药的品种价差与他国相比过大,但一些原研药仍能在公立药品采购系统中有一席之地。原研药和通用名药"共生"的品种,价格与印度相比没有优势,国产通用名药的价格甚至高于印度品牌通用名药。  相似文献
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Bioavailability and/or bioequivalence studies play a key role in the drug development period for both new drug products and their generic equivalents. For both, these studies are also important in the postapproval period in the presence of certain manufacturing changes. Like many regulatory studies, the assessment of bioavailability and bioequivalence can generally be achieved by considering the following three questions. What is the primary question of the study? What are the tests that can be used to address the question? What degree of confidence is needed for the test outcome? This article reviews the regulatory science of bioavailability and bioequivalence and provides FDA's recommendations for drug sponsors who intend to establish bioavailability and/or demonstrate bioequivalence for their pharmaceutical products during the developmental process or after approval.  相似文献
6.
Objective: The 13/01/01 French decree published an official list of brands and their generic drugs and identified 38 groups of excipients with known effects which are responsible for side effects and contraindication respectively. Our objective was to review all medicines marketed in France containing these excipients and to disseminate this information to French health care practitioners.Method : The side effects and contraindications regarding these excipients have been documented in the French drug database Theriaque ( http://www.theriaque.org) . They were documented for each medicine containing these excipients in addition to the data mentioned in the Summary of Product Characteristics ( SPC) . Results were obtained on 1 June 2001 by using computerised queries from the database. Results: Within the 38 groups, 300 specific excipients and derivatives with known effects were identified. Among the 8900 medicines ( 100% ) , 5567 medicines ( 62.6% ) contained one or more of these excipients; 2483 contained 1 excipient, 1819 contained 2 excipients and 1265 contained 3 or more excipients; 410 side effects or contra indications – were described according to the route of administration and the threshold dose. They were linked to these 5567 medicines; 5818 excipients with a threshold dose were mentioned in the 'composition' sections of these 5567 medicines. Among these 5818 excipients, 3385 quantitative doses were documented in the SPCs or EPARs.Conclusion: This review shows the extent of most of the excipients contained in medicines marketed in France. The dissemination of these data offsets the lack of information in the SPCs.  相似文献
7.
Objective: In 1999, a new law was introduced, giving French pharmacists the right to switch from branded to generic drugs, unless the prescriber had specified that substitution was not permitted. The purpose of this study was to assess the opinion and behaviour of community pharmacists towards substitution.Design: Selfcompletion, postal closeended questionnaires were filled out.Sample and setting: 1,000 French community pharmacists were includedResults: 90% of the pharmacists were favourable to the implementation of the substitution right. 42.5% declared they systematically offered patients the generic drug, whereas 55% chose to target specific populations for substitution. The reluctance of pharmacists could be commercial ('How do I get paid for the time spent? Is it worth risking loosing a customer?'), or cultural ('How do I work this out? Who should I offer generic drugs to? What strategy should I use to offer them?').Conclusion: Generic drug distribution is very recent in France and is not yet common practice. Pharmacists and patients must be informed and trained because substitution is a collaborative act. It does not depend solely on the will and experience of pharmacists.  相似文献
8.
严中平  陈玉文 《中国药房》2005,16(19):1452-1454
目的:为我国制药企业确立非专利药市场发展策略提供参考。方法:以市场营销学原理为基础,采用文献检索和实证分析法。结果与结论:总结出我国非专利药市场存在的主要问题,并提出根据企业特点,选择特色品种;实现营销创新,关注农村市场,扩大市场份额;建立战略联盟,合作竞争,打造非专利药龙头;创立非专利药品牌,占领高端市场等可行的策略。  相似文献
9.
A comparison of different methods for dissolution test used by five different manufacturer laboratories of lamivudine tablets is made, evaluated, and discussed. Dissolution medium (water and hydrochloric acid pH 1.2), apparatus (paddles and baskets) and time (30 and 60 min) were analyzed. The determination was accomplished by spectrophotometry at 270 nm. Analysis of variance (ANOVA) factorial design 5 × 2 × 2 × 2 with six repetitions, with post hoc multiple comparisons between means conducted by Duncan test at 0.05 significance level was used. After the comparative analysis of the results, optimal dissolution conditions were determined as follows: water as dissolution medium, paddles at the stirring speed of 50 rpm as apparatus and time of 30 min. The method was applied to the dissolution test of samples from eleven batches of tablets, produced by five different laboratories.  相似文献
10.
目的:为完善我国仿制药一致性评价中参比制剂选择机制和程序提供参考,为仿制药企业在应用选择参比制剂时提供思路。方法:详细介绍了美国FDA有关参比制剂选择指南草案的最新描述,以及欧盟、日本和WHO对于参比制剂的相关要求。结合我国现阶段仿制药一致性评价工作实际,为完善参比制剂选择程序提出建议。结果与结论:美国详细规定了仿制药参比制剂的选择思路和实际操作程序,为我国仿制药参比制剂的选择提供了新的思路。我国正处于仿制药一致性评价参比制剂遴选的关键时期,制定全面、完善的参比制剂遴选体系和机制,有助于规范参比制剂的选择程序,加快一致性评价工作进程,提升我国仿制药一致性评价参比制剂选择的科学性和完整性。  相似文献
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