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・その他の投与経路における安全性評価 基本的に経口剤のpde値を使って,製剤特性に応じて値を減らす方針 ・pde値よりも高い量の元素不純物を含む場合の妥当性 サブファクターアプローチの事例を記載 ・注射剤における元素不純物の安全性評価

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