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Exploration of suitable pharmacodynamic parameters for acarbose bioequivalence evaluation: A series of clinical trials with branded acarbose
Author(s) -
Huang Jie,
Liu Wenyu,
Yu Jingjing,
Yang Jinbo,
Li Min,
Zou Chan,
Guo Chengxian,
Yang Xiaoyan,
Yang Shuang,
Xie Jinlian,
Huang Zhijun,
Chen Hui,
Pei Qi,
Yang Guoping
Publication year - 2020
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/bcp.14324
Subject(s) - acarbose , bioequivalence , crossover study , confidence interval , medicine , pharmacodynamics , geometric mean , food and drug administration , pharmacokinetics , pharmacology , endocrinology , mathematics , placebo , diabetes mellitus , statistics , alternative medicine , pathology
To determine deficiencies in the Food and Drug Administration (FDA)'s guidance for assessing acarbose bioequivalence (BE) and to explore optimal pharmacodynamic (PD) metrics for better evaluation of acarbose BE.