Prediction of pharmacokinetic parameters of inhaled indacaterol formulation in healthy volunteers using physiologically-based pharmacokinetic (PBPK) model

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成果类型：

期刊论文

作者：

Tang, Cui;Ou-yang, Chen-xi;Chen, Wen-jing;Zou, Chan;Huang, Jie;...

通讯作者：

Pei, Qi;Yang, GP;Pei, Q

作者机构：

[Pei, Q; Yang, Guo-ping; Tang, Cui] Cent South Univ, XiangYa Sch Pharmaceut Sci, Changsha 410013, Hunan, Peoples R China.

[Yang, Shuang; Cui, Chang; Zou, Chan; Pei, Qi; Huang, Jie; Guo, Can; Pei, Q; Yang, Guo-ping; Chen, Wen-jing; Tang, Cui; Yang, Xiao-yan] Cent South Univ, Xiangya Hosp 3, Ctr Clin Pharmacol, Changsha 410013, Hunan, Peoples R China.

[Ou-yang, Chen-xi] Hunan Univ Chinese Med, Sch Pharm, Changsha 410208, Hunan, Peoples R China.

[Lin, Yu] Chongqing Med & Pharmaceut Coll, Chongqing 401331, Peoples R China.

[Pei, Qi; Pei, Q] Cent South Univ, Xiangya Hosp 3, Dept Pharm, Changsha 410013, Hunan, Peoples R China.

通讯机构：

[Pei, Q; Yang, GP ; Pei, Q ] C

Cent South Univ, XiangYa Sch Pharmaceut Sci, Changsha 410013, Hunan, Peoples R China.

Cent South Univ, Xiangya Hosp 3, Ctr Clin Pharmacol, Changsha 410013, Hunan, Peoples R China.

Cent South Univ, Xiangya Hosp 3, Dept Pharm, Changsha 410013, Hunan, Peoples R China.

Natl Local Joint Engn Lab Drug Clin Evaluat Techn, Changsha 410000, Hunan, Peoples R China.

语种：

英文

关键词：

Indacaterol;Pharmacokinetics;Inhaled formulation;Physiologically-based pharmacokinetic (PBPK);Virtual bioequivalence

期刊：

European Journal of Pharmaceutical Sciences

ISSN：

0928-0987

年：

2022

卷：

168

期：

页码：

106055-

DOI：

10.1016/j.ejps.2021.106055

基金类别：

National Major New Drug Creation Project of China [2020ZX09201-010]; National Scientific Foundation of ChinaNational Natural Science Foundation of China (NSFC) [81302851]; Key Research and Develop-ment Project of Hunan Province [2020SK2010]

机构署名：

本校为其他机构

院系归属：

药学院

摘要：

Background: Inhaled formulations are the first choices for treating asthma and chronic obstructive pulmonary disease (COPD), attracting the increasing investment and development in the pharmaceutical industry. Both the equivalence of local and systemic exposures need to be considered when assessing the equivalence of generic inhaled drugs, which has become a dilemma in the development of generic inhaled drugs. There is an urgent need for reliable methods such as physiologically-based pharmacokinetic (PBPK) model to assist in the development of inhaled drugs.Method: To test the strategy that in...

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Prediction of pharmacokinetic parameters of inhaled indacaterol formulation in healthy volunteers using physiologically-based pharmacokinetic (PBPK) model

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