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Sample size calculation for standard agomelatine bioequivalence study in Chinese healthy volunteers.

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posted on 2014-10-20, 02:42 authored by Qi Pei, Yan Wang, Zhe-Yi Hu, Shi-Kun Liu, Hong-Yi Tan, Cheng-Xian Guo, Ran-Ran Zhang, Yu-Xia Xiang, Jie Huang, Lu Huang, Hong Yuan, Guo-Ping Yang

Sample size calculation for standard agomelatine bioequivalence study in Chinese healthy volunteers.

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    assessment approachSupport Bioequivalence Study ObjectivesWe aimreferencesubjectagomelatine PKbioequivalence assessment strategy.MethodsAcoefficientvariabilityrandomized crossover designsample sizeRSABE approachesantidepressant agomelatinecriteriaaucVariable Agomelatine PharmacokineticsANOVA analysismeasure drug concentrations

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