亚洲社会药学

本期目录

2016年, 第11卷, 第1期　刊出日期：2016-01-07 上一期    下一期

论文

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FDA Emergency Management System for Food and Drug and Its Enlightenment to China 2016 (1):  1-6.  摘要 ( 256 )   PDF(344KB) ( 298 )   Objective To provide suggestions for improving food and drug emergency management system in China. Methods Literature review was applied to study FDA emergency management system from four aspects: emergency operation plan, legal system, organization system and mechanism of emergency operation. And suggestions were raised to improve related works in China. Results and Conclusion Emergency management provisions on food and drug should be perfected to refine the emergency operation plan, and to accelerate the setup of food and drug safety monitoring and early warning systems. 相关文章 | 计量指标

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Factors Affecting the Safety of Drug Clinical Trials 2016 (1):  7-18.  摘要 ( 277 )   PDF(574KB) ( 179 )   Objective To promote the development of drug clinical trials. Methods Thirty experts of drug clinical trials were interviewed through analytic hierarchy process (ahp) to obtain the factors affecting the safety of drug clinical trials. And Matlab software was used to analyze the weight of each factor so that a systematic evaluation of the factors could be made. Result and Conclusion Laboratory inspection process and sense of responsibility of adverse event related staffs were the key factors affecting the safety of drug clinical trials; the system of drug clinical trials was in the second place; and the management of the organization was in the last place. Therefore, it is suggested that a perfect system should be established to improve the quality of related staffs and to strengthen the supervision so as to protect the interests of the subjects in drug clinical trials. 相关文章 | 计量指标

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U.S. and China: New Drug Review Procedures and Openness 2016 (1):  19-24.  摘要 ( 283 )   PDF(348KB) ( 312 )   Objective To provide references for reforming new drug review procedures in China. Methods Relevant principles and literatures on drug registration management were studied to analyze new drug review procedures and openness in the United States. Some experiences were learned for optimizing new drug approval system in China, combined with the newly issued the State Council’s Opinion on the Reform of the System for Drug and Medical Device Evaluation and Approval. Results and Conclusion It will contribute to improving drug review and approval system and promoting new drugs research and development in China by learning the experiences of U.S. on new drug review and approval procedure and openness, such as optimizing the clinical administration, application procedure and review on division of labor; changing the constitution of drug review committee and releasing the drug review report, etc. 相关文章 | 计量指标

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A Comparison Study Between EQ-5D-3L and the New Version EQ-5D-5L 2016 (1):  25-30.  摘要 ( 379 )   PDF(537KB) ( 570 )   Objective To make a comparison study between EQ-5D-5L and EQ-5D-3L in order to promote the application of EQ-5D-5L. Methods A survey of 240 respondents was done and the performance of EQ-5D-3L and EQ-5D-5L was assessed according to the inconsistency and redistribution properties at all levels. The discriminatory power and sensitivity of EQ-5D-3L and EQ-5D-5L were explored according to Shannon index (H’), Shannon evenness index (J’) and ceiling effect. And the reliability and validity of EQ-5D- 3L and EQ-5D-5L were analyzed according to Cronbach’α and criterion validity. Results and Conclusion The average inconsistent rate and size of EQ-5D-3L and EQ-5D-5L were 2.33% and 1.04, respectively. Compared with EQ-5D-3L, the state of health of EQ- 5D-5L dropped from 74.17% to 65.42%, and the ceiling effect decreased as well. The Shannon indexes of all dimensions of EQ- 5D-5L were better than EQ-5D-3L. Except for pain/discomfort, the Shannon evenness indexes of EQ-5D-5L were also better than EQ-5D-3L. The Cronbach’α of EQ-5D-5L increased from 0.514 to 0.707. Except for self-care, the Spearman’s rank correlation coefficient between EQ-5D-5L and EQ-VAS also increased. Therefore, EQ-5D-5L gains more advantages than EQ-5D-3L and should be promoted. 相关文章 | 计量指标

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Comparative Analysis of EQ-5D and SF-6D Used for Diabetics 2016 (1):  31-36.  摘要 ( 284 )   PDF(377KB) ( 291 )   Objective To compare the reliability and validity of EQ-5D and SF-6D for measuring the diabetics’ quality of life. Methods Patients with type 2 diabetes in endocrinology clinic of Beijing Hospital were studied. Information including social demographic data, disease, EQ-5D, SF-6D, diabetics’ quality of life was collected in questionnaire (DSQL) after patients’ consent. And SPSS statistical was used to analyze the result of the questionnaire so that the reliability and validity of EQ-5D and SF-6D were evaluated. Results and Conclusion EQ-5D and SF-6D value sets are more operable compared with other general instrument. And they can be applied to all respondents due to their simplicity. EQ-5D and SF-6D are suitable for measuring patients’ quality of life, and SF-6D is better than EQ-5D as to reliability and validity. 相关文章 | 计量指标

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The Application of HACCP System in Drug Distribution 2016 (1):  37-41.  摘要 ( 387 )   PDF(353KB) ( 245 )   Objective To introduce the hazard analysis and critical control point (HACCP) system in drug distribution so as to reduce safety risks. Methods A risk analysis was made to define the critical points, establish a monitoring system and to adopt corrective actions in accordance with HACCP principles. Results and Conclusion It would be helpful for drug distribution industry to strengthen risk management to guarantee the quality of drugs in distribution process. 相关文章 | 计量指标