@article{oai:dwcla.repo.nii.ac.jp:00000738, author = {成橋, 和正 and NARUHASHI, Kazumasa}, journal = {総合文化研究所紀要, Bulletin of Institute for Interdisciplinary Studies of Culture Doshisha Women’s College of Liberal Arts}, month = {Mar}, note = {application/pdf, AN10052143-20120330-132, Generic medicines are recommended to be used in Japan recently, therefore, pharmacists have to evaluate their quality in altering from brand to generic drugs. In those cases, evaluation should be based on both pharmaceuticals and information. Equivalence of bioavailability is guaranteed in approval by Ministry of Health, Labour and Welfare, however, pharmaceutical evaluation is not fully compared. Objective evaluation of the information is not systematically done. Therefore, this study evaluated the 16 brand and generic tablets of nitrendipine that are commercially available in Japan. In the comparison of pharmaceutical additives, each brand or generic has unique combination of variety of additives. This study also compared the pharmacokinetic parameters indicated in the package insert. Although the conditions of the clinical examinations were very similar, the difference of the values of Cmax or AUC was more than double. These results indicate the difficulty in comparing these values among different generic tablets. This study also evaluated the information in terms of its contents, availability and accessibility. The contents were evaluated according to criteria for evaluation of drug information 3rd edition, and the availability and accessibility were graded according to new criteria. The points of contents, availability and accessibility were 27.4-90.8 (full mark: 100), 11-42 (full mark: 42) and 0-18 (full mark: 18), respectively, resulting in the total of 38.4 to 147.8 (full mark: 160), indicating a wide range in the quality in information., 論文 (Article)}, pages = {132--142}, title = {先発品・後発品情報の内容、利用可能度、入手難易度の比較と評価 : ニトレンジピン錠}, volume = {29}, year = {2012}, yomi = {ナルハシ, カズマサ} }