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The maximum concentration (C max, ng/ml) of risperidone for the innovator and the generic product were 31.11–17.24 (range 5.64 … FDA will consider any comments on the revised draft BE recommendations in responding to the petition.This draft guidance is being issued consistent with FDA's good guidance practices regulation (Persons with access to the Internet may obtain the draft guidance at either 0000175680 00000 n
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Bioequivalence and Pharmacokinetic Evaluation of Two Formulations of Risperidone 2 mg An Open-Label, Single-Dose, Fasting, Randomized-Sequence, Two-Way Crossover Study in Healthy Male Chinese Volunteers Yun Liu • Meng-qi Zhang • Jing-ying Jia • Yan-mei Liu • Gang-yi Liu • Shui-jun Li • Wei Wang • Li-ping Weng • Chen Yu Published online: 21 December 2012 The Author(s) …