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亚洲社会药学

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玻璃钢/复合材料

	2024年 19卷 1期
	刊出日期 2024-03-10

	1	Yu Hanshuang, Huang Xianqin, Wang Huiyan, Sun Lihua
		Research on Reimbursement Management of Innovative Drugs Abroad and Its Enlightenment to China
		Objective To analyze the reimbursement policies of innovative drugs in some developed countries, and to provide reference for future reimbursement management in China. Methods Literature research method was used to study the policies related to the reimbursement management of innovative drugs in Germany, France and Japan, and their successful experience was summarized. Results and Conclusion China should establish an open and transparent value evaluation standard to improve the medical insurance reimbursement management of innovative drugs. Besides, the value of innovative drugs should be taken as an important basis for reimbursement decisions, and an independent third-party value evaluation agency must be established.
		2024 Vol. 19 (1): 1-8 [摘要] ( 50 ) [HTML 1KB] [ PDF 486KB] ( 42 )

	9	Lin Xueyi, Pang Li, Huang Zhe, Lian Guiyu
		Research and Enlightenment of Text Mining Applications in ADR from Social Media
		Objective To discuss how to use social media data for post-marketing drug safety monitoring in China as soon as possible by systematically combing the text mining applications, and to provide new ideas and methods for pharmacovigilance. Methods Relevant domestic and foreign literature was used to explore text classification based on machine learning, text mining based on deep learning (neural networks) and adverse drug reaction (ADR) terminology. Results and Conclusion Text classification based on traditional machine learning mainly include support vector machine (SVM) algorithm, naive Bayesian (NB) classifier, decision tree, hidden Markov model (HMM) and bidirectional en-coder representations from transformers (BERT). The main neural network text mining based on deep learning are convolution neural network (CNN), recurrent neural network (RNN) and long short-term memory (LSTM). ADR terminology standardization tools mainly include “Medical Dictionary for Regulatory Activities” (MedDRA), “WHODrug” and “Systematized Nomenclature of Medicine-Clinical Terms” (SNOMED CT).
		2024 Vol. 19 (1): 9-19 [摘要] ( 33 ) [HTML 1KB] [ PDF 571KB] ( 18 )

	20	Zhang Yuting, Liu Xiaoxi
		Research on the Status Quo and Optimization of Centralized Procurement of Coronary Stents
		Objective To study the impact of the first national centralized procurement of coronary stents on patients’ psychology, the economy of medical institutions, and the survival and development of the coronary stents industry, and to provide suggestions on perfecting procedures to better carry out the centralized procurement of coronary stents. Methods Literature analysis was used to investigate the results of the procurement of coronary stent in a province and a hospital. Results and Conclusion The centralized procurement of coronary stents has alleviated the economic pressure of patients, but it has many problems. Therefore, this paper proposes some suggestions, such as promoting the orderly development of the coronary stent industry, improving the evaluation link of the centralized procurement of coronary stents, adopting the accurate reporting model to ensure the quality of coronary stents and improving the standardization of clinical services.
		2024 Vol. 19 (1): 20-28 [摘要] ( 28 ) [HTML 1KB] [ PDF 433KB] ( 10 )

	29	Diao Yuanyuan, Wu Zhiang
		Analytic Hierarchy Process for Technological Risks in the Process of Innovative Drug Development in China
		Objective To identify the critical risks in the process of innovative drug research and development, and to provide reference for improving the efficiency of innovative drug development and risk control in China. Methods Expert investigation and analytic hierarchy process were used to determine the weights of different risks. Results and Conclusion The research and analysis results showed that the risks at different stages of development had different effects on the success rate of drug development, among which the risk at the drug discovery stage influenced the most. In the drug discovery stage, inappropriate target selection had the greatest impact on the success rate of drug development. The lack of appropriate cell tissue or animal models had the greatest impact on the success rate of drug development from the discovery of a compound to the application for clinical trials. The difference in changes between nonclinical and clinical studies had the greatest impact on the success rate of drug development from early clinical studies to pivotal clinical studies. Incorrect dose selection had the greatest impact on the success rate of drug development from pivotal clinical studies to marketing authorization applications. The biggest impact from the marketing authorization application to the approval stage was inadequate communication with regulators. After investigating the weight of risk factors in the process of innovative drug development based on scientific methods, a new perspective for the risk control of new drug development and improving the research and development efficiency is provided.
		2024 Vol. 19 (1): 29-42 [摘要] ( 25 ) [HTML 1KB] [ PDF 614KB] ( 12 )

	43	Gong Jingran, Chang Yingnan, Qiao Jiahui, Chen Yuwen
		Comparative Study on the Policy of Multiplicity Issues in Clinical Trials at Home and Abroad
		Objective To study the content of China’s guiding principles on multiplicity issues in clinical trials, and to provide reference for the revision of China’s relevant guiding principles. Methods Based on ICH E9, the similarities and differences of the guiding principles of US Food and Drug Administration (FDA), European Medicines Agency (EMA), and National Medical Products Administration (NMPA) on the multiplicity issues in clinical trials were compared one by one. Results and Conclusion In general, NMPA guidelines are based on ICH E9, but in detail, the guidelines of FDA and EMA focus differently on the multiplicity issues. Therefore, NMPA guidelines need to be detailed and comprehensive. NMPA guidelines can be refined by referring to foreign guidelines to improve the practical guiding significance for clinical research and promote the level of domestic clinical trials in line with international standards.
		2024 Vol. 19 (1): 43-49 [摘要] ( 28 ) [HTML 1KB] [ PDF 443KB] ( 10 )

	50	Lin Hansen, Tian Lijuan
		An Overview of Quality Management of Therapeutic Vaccines in Clinical Trials in China
		Objective To provide suggestions and a reference for improving the quality management system of clinical trials of therapeutic vaccines and promoting the development of therapeutic vaccines in China. Methods Literature research, case study and comparative study were used to analyze the quality management system of clinical trials of therapeutic vaccines. Results and Conclusion From the perspective of the sponsor, investigators and the third-party technical service company, the problems such as the low efficiency of clinical trial sample preparation and the lax implementation of the protocol by hospital departments in the quality management of clinical trials of therapeutic vaccines in China were found. Then, the optimization plan for the quality management of clinical trials of therapeutic vaccines is proposed, including optimizing the preparation process of therapeutic vaccines and strengthening the training of hospital department personnel.
		2024 Vol. 19 (1): 50-57 [摘要] ( 23 ) [HTML 1KB] [ PDF 428KB] ( 10 )

	58	Yang Xiuqiao, Wen Ping, Lin Hong, Chen Wenhuan, Chen Yuwen
		Problems and Countermeasures to Improve Clinical Trial Participants’ Compensation Rights in China
		Objective To discuss the problems existing in the compensation of Chinese clinical trial participants and propose some suggestions for improving their rights. Methods The literature related to the participants’ right to compensation at home and abroad was searched to study the inadequacy of the compensation right for clinical trial participants in China from four aspects: insurance system, principle of attribution, legal relationship and compensation regulations. Then, some suggestions to improve the participants’ right to compensation were proposed. Results and Conclusion China lacks clear legal norms for participants’ right to compensation. There are problems such as unclear insurance rules and compensation rules, unclear contractual relationships between parties to clinical trials, and no laws and regulations to rely on for attribution and compensation. China should issue regulatory guidelines related to the right to compensation of participants in clinical trials, so that all parties in clinical trials can have rules to follow if there is the occurrence of injury, which can better protect the rights and interests of the participants.
		2024 Vol. 19 (1): 58-63 [摘要] ( 24 ) [HTML 1KB] [ PDF 415KB] ( 6 )

	64	Wang Jianing, Wang Shuling
		Research on the Status Quo and Countermeasures of Human Resource Management Outsourcing in China’s Pharmaceutical Enterprises
		Objective To explore the current situation of human resource management outsourcing in China’s pharmaceutical enterprises, and to put forward some suggestions for enterprises and the government. Methods The current situation of human resource management outsourcing in China’s pharmaceutical enterprises was analyzed through the method of literature research. Results and Conclusion At present, the status of human resource management outsourcing in China’s pharmaceutical companies is that the level of human resource outsourcing companies is not high, and there are no relevant industry norms and laws. The information asymmetry between pharmaceutical enterprises and outsourcing companies results in adverse selection and moral hazard. Besides, the different culture of pharmaceutical enterprises and outsourcing companies leads to inefficient communication between enterprises and employee. To solve these problems, the government should promote and improve industry norms and laws to regulate the market. In addition, enterprises should clarify the motivation for outsourcing and make good decision on the outsourcing content. Meanwhile, enterprises should strengthen communication with employees to eliminate employees’ concerns.
		2024 Vol. 19 (1): 64-71 [摘要] ( 21 ) [HTML 1KB] [ PDF 420KB] ( 8 )

	72	Gao Lin, Sun Lihua
		An Exploration of Organizational Development in the Process of Innovation and Transformation of Pharmaceutical Enterprises - Taking X Pharmaceutical Enterprise as an Example
		Objective To study how to promote the smooth innovation and transformation of enterprises and enhance the market competitiveness of enterprises from the perspective of human resources organization development. In the wave of pharmaceutical industry reform, some entrepreneurs realize the importance of innovation and technology in the future. However, domestic pharmaceutical enterprises are still in the production-oriented stage. In the process of transformative innovation, pharmaceutical enterprises should not only rely on the support of scientific and technological and economic forces, but also need a suitable organizational change and many excellent talents as the source of development. Methods Through retrieving relevant literature and combined with the organizational development practice of X pharmaceutical enterprise, the organizational development model was explored in this paper. Results and Conclusion By forming a system of strategy, organization, talent, culture and mechanism, and building an organizational development model, we can improve the organizational atmosphere and organizational efficiency in the process of enterprise innovation and transformation, so as to enhance the competitiveness of enterprises in the market.
		2024 Vol. 19 (1): 72-80 [摘要] ( 33 ) [HTML 1KB] [ PDF 568KB] ( 6 )

	81	Qu Simeng, Wang Shuling
		Comparative Analysis of Profit Model of Typical Pharmaceutical O2O Enterprises in China
		Objective To study the profit model of Chinese pharmaceutical O2O enterprises. Methods A case study of three typical pharmaceutical O2O enterprises was conducted, and their profit models were compared. Results and Conclusion The pharmaceutical O2O enterprises in China are divided into three categories according to the profit models. It is found that the current pharmaceutical O2O enterprises have problems such as simple profit model and low corporate profits. Based on these problems, it is recommended that relevant enterprises develop various business models to increase profit channels. Besides, they should establish and improve internal cost control systems.
		2024 Vol. 19 (1): 81-88 [摘要] ( 23 ) [HTML 1KB] [ PDF 523KB] ( 8 )

	89	Zeng Yingying, Liu Tong, Liu Yue, Song Aiwei, Yuan Hongmei
		*Analysis of Patent Application Status of Scutellaria Barbata* Industrial Chain Based on Patent Data**
		Objective To analyze patent application status of Scutellaria Barbata industrial chain and provide some suggestions for its patent application and product development. Methods Patent data were collected through IncoPat patent analysis system. Meanwhile, the patent analysis method combined with text mining method was adopted to analyze the situation and development trend of patent application in China’s Scutellaria Barbata industrial chain by using pie chart, bubble chart, trend chart and other visual charts to display the results. Results and Conclusion The patent application of Scutellaria Barbata in China mainly experienced three stages: Slow development, rapid development, and recession period. The number of patents is large, but the authorization rate is low. Individuals and enterprises are the main applicants for patent applications. Product development is involved in the whole industrial chain, but it basically focuses on its efficacy in downstream drugs, health food and other aspects. Therefore, government should enhance the awareness of patent protection, encourage collaborative innovation in industry-university-research to promote the combination of basic research and market application. Besides, it should provide theoretical support to tackle the problem of short board products, which can promote the transformation of scientific and technological achievements and contribute to the upgrading of Scutellaria Barbata industrial chain.
		2024 Vol. 19 (1): 89-97 [摘要] ( 21 ) [HTML 1KB] [ PDF 1621KB] ( 7 )