亚洲社会药学

本期目录

2015年, 第10卷, 第4期　刊出日期：2015-12-20 上一期    下一期

论文

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Toxic TCM Supervision: Current Situations and Countermeasures CAO Ming-cheng;HUANG Tai-kang* 2015 (4):  171-175.  doi: 摘要 ( 240 )   Objective To put forward suggestions for effective supervision of toxic traditional Chinese medicine (TCM) in China. Methods Classification and supervision of toxic TCM were analyzed and suggestions for the supervision of toxic TCM were given. Results and Conclusion Current situations of the supervision of toxic TCM are studied and countermeasures are raised. 相关文章 | 计量指标

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WHO Prequalification of Medicines Program:Technical Assistance Effect HUANG Bao-bin;FOERG-WIMMER Christina;SMID Milan;WU Zhi-ang;WU Chun-fu* 2015 (4):  176-183.  doi: 摘要 ( 234 )   Objective To evaluate the effect of technical assistance organized by WHO in order to provide effective technical assistance to China’s pharmaceutical manufacturers for reaching the standards of WHO prequalification. Methods Assessment tools and questionnaires for interview were designed, and the effect of technical assistances conducted in 4 domestic firms producing antituberculosis medicines in China was evaluated. Results and Conclusion The compliance with standards of WHO prequalification was upgraded at different scales among 4 firms accepting technical assistance. In production, it increased from an average of 53% to 80% for quality management system, and 70% to 80% for good manufacturing practices; in regulatory dossier, it increased from 28% to 67% for quality part, and from zero to 75% for efficacy and safety part. Interviews also showed difficulties faced by firms in terms of market share, regulation policies and cooperation of key partners in medicines development chain, etc. Technical assistances organized by WHO were effective in improving the compliance with the standards of WHO prequalification. However, the arrangement could be further improved and sustainability should be emphasized. 相关文章 | 计量指标

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Drug Evaluation Programs in China: Problems and Countermeasures WANG Lei;CHEN Yu-wen*;HAO Gui-ming 2015 (4):  184-186.  doi: 摘要 ( 265 )   Objective To put forward suggestions for drug evaluation programs in China. Methods Problems of drug evaluation programs were analyzed through literature overview and field research. Results and Conclusion There exist some problems and defects in drug evaluation programs in China. It is suggested that sampling and testing programs can be improved to optimize drug evaluation programs in China. 相关文章 | 计量指标

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Drug Registration and Approval System in China: CurrentStatus, Controversies and Future Perspectives ZHAO Jun-rui;NI Jing-yun;SI TOU Ka-weng;HU Yuan-jia* 2015 (4):  187-196.  doi: 摘要 ( 293 )   Objective To present a comprehensive analysis on the current status and controversies of China’s drug registration and approval system in transition period and to disclose the future direction and trends by analyzing the draft amendment to Drug Registration Regulation (DRR) as well as relevant notices. Methods Literature review, qualitative analysis, and descriptive statistics were applied. Results and Conclusion Current DRR in China seems incompatible and outdated in a number of respects, such as approval timelines, generic drug registration, binding authorization mode, amending clinical protocols, and new drug observation periods. Draft amendments to DRR as well as relevant notices for public comment released by Chinese regulatory authorities show partial responses to current status and controversies. The draft amendment indicates a future direction and tendency for drug registration and approval. On the basis that the China Food and Drug Administration (CFDA) is attempting to improve the efficiency of the approval process, the amendments will further encourage drug R&D and help to restore confidence among both the public and the drug manufacturers. 相关文章 | 计量指标

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Analysis of TCM Patented Technology Based onthe IPC Classification System DING Lei;WEI Ying;CHEN Yan;YUAN Hong-mei* 2015 (4):  197-202.  doi: 摘要 ( 260 )   Objective To explore the trend of traditional Chinese medicine (TCM) R&D and patent applications on the basis of technical coverage of Chinese medicine enterprises. Methods Multidimensional data analysis was made based on 73,459 patents approved by the State Intellectual Property Office before 2013 from the aspects of the concentration of (international patent classification) IPC large groups for invention patents, the trend of patent applications for TCM and the interdisciplinary phenomenon of typical Chinese medicine enterprises. Results and Conclusion Fields of A61K35 and A61K26 patent application are the hotspots of TCM R&D from the perspective of IPC, and it is increasing year by year. Drug research for gastrointestinal or digestive diseases is another hotspot for the development of TCM from drug’s therapeutic activity aspects. In addition, it is found that the number of patents from Tasly Company is larger than that of Yiling Company, which indicates Tasly Company has a broader range of TCM patented technology. 相关文章 | 计量指标

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Detection and Analysis on Outlier of the AverageMedical Expense in China YANG Yang;ZHANG Fang*;XIANG Rong-wu 2015 (4):  203-208.  doi: 摘要 ( 250 )   Objective To analyze 4 outlier detection methods so as to select a relatively simple and accurate one, thus to provide a reference for predicting the tendency of average medical expense in China. Methods Comparison, Dixon’s test, Hampel’s test and Grubb’s methods were used. Results and Conclusion Dixon’s and Hampel’s test methods are more convenient than T test and Grubb’s methods but they have poor sensitivity. There are many factors affecting medical expense per capita trend in China, such as the aging population and the financial crisis. 相关文章 | 计量指标

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A Study on the Contract Research Organization LIANG Yu;TIAN Li-juan* 2015 (4):  209-213.  doi: 摘要 ( 254 )   Objective To provide a reference for the development of contract research organizations. Methods Literature was studied to summarize the development background, current status of the contract research organizations and the problems they were facing. Results and Conclusion Contract research organizations should take measures from the following aspects, such as international cooperation, contract research organization union, industry chain, quality authentication system and talent training, etc. to accelerate its development. 相关文章 | 计量指标

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An Empirical Study on Model of Consumers’ Initial Trustin Online Pharmacies HAN Xue-ting;HUANG Zhe* 2015 (4):  214-221.  doi: 摘要 ( 255 )   Objective To put forward some suggestions for developing consumers’ initial trust in online pharmacies. Methods Literature on consumers’ initial trust in online pharmacies was analyzed and a model of consumers’ initial trust in online pharmacies and 9 hypotheses were proposed. A total of 207 valid samples were also studied with the questionnaires and AMOS. Results and Conclusion Some factors such as website usability, website simplicity, structural assurance, and trust tendency would influence consumers’ initial trust and their purchasing behaviors. Online pharmacies can improve consumers’ initial trust by enhancing website quality, building trust mechanism and focusing on consumers’ personal characteristics. 相关文章 | 计量指标

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Improving the Development of Online Pharmacies in China GUO Ying* 2015 (4):  222-226.  doi: 摘要 ( 265 )   Objective To put forward some suggestions for the perfection of online pharmacies in China. Methods Literature review and research papers in CNKI were studied and existing problems of online pharmacies in China were analyzed including ineffective supervision system, inadequate online consumers, slow logistics and distribution system, etc. Results and Conclusion Development of online pharmacies in China can be improved by optimizing government supervision system, strengthening the connection between online pharmacies and health care system and perfecting the logistics system. 相关文章 | 计量指标