2014年に日本で承認された新医療用製剤に対し､安定性試験の現状を調査した｡我々は､2014年に安定性試験の記述がある134の新医療用製剤を特定した｡長期保存試験としては､82製剤が25±2℃/60±5%相対湿度の条件下で､48製剤が5±3℃の条件下で､4製剤が10℃未満の条件下で試験が実施されていた｡また､光安定性試験では､78製剤が光学的に安定であったが､48製剤は光学的に不安定であった.光学的に不安定な製剤は､遮光保存をするといった適切な保存方法がとられている.これらの結果から､2014年に日本で承認された新医療用製剤は､ICH ｶﾞｲﾄﾞﾗｲﾝに従って､適正に承認されていることがわかった｡We investigated the current status of stability testing of new drug products in Japan. One hundred thirty-four new drug products that had undergone stability testing in 2014 were identified. Among these, 82 were tested at 25℃ ± 2℃ / 60% ± 5% relative humidity, 48 were tested at 5℃ ± 3℃, and 4 were tested at less than 10℃ on long-term testing. Based on photostability testing, 78 new drug products were found to be optically stable and 48 were optically unstable. New drug products that appeared unstable in photostability testing were stored in the dark. Based on these results, the new drug products approved in Japan according to the ICH guidelines in 2014 were found to have been adequately tested
