著者

小室 雅人 折井 啓一郎 小野寺 祐加 白神 誠

出版者

一般社団法人日本医薬品情報学会

雑誌

医薬品情報学 (ISSN:13451464)

巻号頁・発行日

vol.15, no.3, pp.111-117, 2013 (Released:2013-12-27)

参考文献数

6

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Objective: If product information provided by pharmaceutical manufactures is not consistent with a product assessment made by the Pharmaceuticals and Medical Devices Agency (PMDA), users may gain false perceptions about the product, which may be detrimental to patients.  An investigation was conducted to compare the contents of product information provided by pharmaceutical manufacturers and product evaluation reports prepared by PMDA to identify any discrepancies between data assessment in the two documents.Methods: Descriptions in “Product Characteristics” and “Clinical Studies” of product information summaries were compared with product evaluation reports prepared by PMDA.  Inquiries were addressed to manufacturers if any questions arose.Results: The investigation was conducted on 66 new active ingredients approved in 2009 to 2010.  As 14 questions arose with 12 ingredients, inquiries were addressed to manufacturers, all of whom offered a response.  As a result, four questions were resolved for two ingredients.  However, for the remaining products, it was revealed that the manufacturers described in the product information summaries what they claimed at the time of submission even though their claims were not accepted by PMDA.Conclusion: It was considered that the pharmaceutical manufacturers possibly did not comprehend the contents of the PMDA’s evaluation reports.  It was suggested that the industry as a whole should examine the issue.  As discrepancies were observed even in product information summaries, which are viewed by a relatively large number of people, it was assumed that more issues may be found in promotional materials provided exclusively to healthcare professionals.

著者

小室 雅人 栗橋 祐介 牛渡 裕二 鈴木 健太郎 岸 徳光

出版者

土木学会

雑誌

構造工学論文集 A (ISSN:18816614)

巻号頁・発行日

vol.62, pp.1011-1018, 2016

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In this study, in order to establish a simple and engineered analysis method for appropriately evaluating the dynamic response characteristics of steel beams under impact loading, impact response analysis method based on a fiber element approach was proposed. An applicability of the method was discussed comparing with the experimental results of a total of nine small-scale H-shaped steel beams having different span length and impact velocities of impact striker. From this study, the following results were obtained: 1) applying the proposed method, the deflection behavior of the beams can be appropriately predicted; and then 2) the method may be able to use as a tool for evaluation of the dynamic response characteristics of the H-shaped steel beams under the impact loading.