後発医薬品メーカーに対する後発医薬品の情報提供に関する調査とその解析

概要

論文の詳細を見る
In recent years, there has been a growing trend to use generic drugs. In view of this, we sent a questionnaire to 39 generic drug manufacturers (belonging to the Japan Generic Pharmaceutical Manufactures Association) to investigate the situation of information provided for them.Twenty-six companies (recovery rate 66.7%) responded and their answers revealed that product information is openly provided for 80% of generic drugs ; for instance the results of dissolution tests and stability tests conducted on packaged products, biological equivalency data, and clinical information. In product summaries, the results of dissolution tests were provided for 56.1% products, and stability data for 19.6% of products. Serum concentration to time curve data was provided in an interview form for 85% of products and in package inserts for 53.3%. For more than half of all the generic drugs, information on only 3 items was available on the Internet. Further, there were wide differences among the manufacturers in the amount of drug information provided.It was felt that manufacturers with fully functional information delivery systems already in place were making efforts to supply good quality information. Those in the process of creating information delivery systems should complete them as quickly as possible and such efforts would serve to further expand the use of generic drugs.
日本医療薬学会の論文