关键词：
drug information
package insert information
investigational drug information
pharmaceutical industry
摘要：
The pharmaceutical industry must always endeavor to collect and evaluate information on efficacy, safety, and quality of drugs, and in a timely manner provide relevant information to medical professionals as well as to patients. Daiichi pharmaceutical Co. Ltd.'s PMS Administration Department developed a drug information database system (Advanced Medical Online Network of Daiichi [AMOND]), and upgraded the system (AMOND-II) in December 1993. This upgraded system included a function for a package insert information system where drug information obtained during development and after launch can be retrieved. From results of analysis of utilization of the new system, it was realized that medical representatives (MRs) and the MR support staff at branch offices need information on only a few specific products, and retrieve package insert information on those products using this system. In contrast, the needs of headquarters staff are nor limited to information on specific products and they use this system to obtain information on drugs meeting specific requirements. How package insert information should be provided has been the subject of active discussion. This paper presents the functions of the package insert information system developed at Daiichi Pharmaceutical, its utilization within the company, and Daiichi pharmaceutical's perspective on the system.
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详细信息
中文科技期刊
