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Exploration of suitable pharmacodynamic parameters for acarbose bioequivalence evaluation: A series of clinical trials with branded acarbose

机译:氨基糖生物等效评价合适药效参数的探索:一系列与品牌氨基糖的临床试验

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摘要

Aims 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.
机译:旨在确定美国食品和药物管理局(FDA)评估阿卡波糖生物等效性(BE)指南中的不足之处,并探索最佳药效学(PD)指标,以更好地评估阿卡波糖BE。

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  • 作者单位

    Cent South Univ Xiangya Hosp 3 Ctr Clin Pharmacol 138 TongZiPo Rd Changsha 410013 Hunan;

    Cent South Univ Xiangya Hosp 3 Ctr Clin Pharmacol 138 TongZiPo Rd Changsha 410013 Hunan;

    Cent South Univ Xiangya Hosp 3 Ctr Clin Pharmacol 138 TongZiPo Rd Changsha 410013 Hunan;

    Natl Med Prod Adm Ctr Drug Evaluat Beijing Peoples R China;

    Natl Med Prod Adm Ctr Drug Evaluat Beijing Peoples R China;

    Cent South Univ Xiangya Hosp 3 Ctr Clin Pharmacol 138 TongZiPo Rd Changsha 410013 Hunan;

    Cent South Univ Xiangya Hosp 3 Ctr Clin Pharmacol 138 TongZiPo Rd Changsha 410013 Hunan;

    Cent South Univ Xiangya Hosp 3 Ctr Clin Pharmacol 138 TongZiPo Rd Changsha 410013 Hunan;

    Cent South Univ Xiangya Hosp 3 Ctr Clin Pharmacol 138 TongZiPo Rd Changsha 410013 Hunan;

    Cent South Univ Xiangya Hosp 3 Ctr Clin Pharmacol 138 TongZiPo Rd Changsha 410013 Hunan;

    Cent South Univ Xiangya Hosp 3 Ctr Clin Pharmacol 138 TongZiPo Rd Changsha 410013 Hunan;

    Cent South Univ Clinc Lab Ctr Xiangya Hosp 3 Changsha Hunan Peoples R China;

    Cent South Univ Xiangya Hosp 3 Dept Pharm 138 TongZiPo Rd Changsha 410013 Hunan Peoples R;

    Cent South Univ Xiangya Hosp 3 Ctr Clin Pharmacol 138 TongZiPo Rd Changsha 410013 Hunan;

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  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 药理学;
  • 关键词

    acarbose; bioequivalence; Food and Drug Administration guidance; individual variation; pharmacodynamic parameters;

    机译:acarbose;生物等效;食物和药物管理指导;个人变异;药物动力学参数;

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