Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products of agomelatine in Chinese subjects.

Tang, Fang; Zhou, Rui; Cheng, Zeneng; Yang, Guoping; Chen, Aiqiao; Liu, Zhi; Tan, Hongyi; Yang, Shuang; Li, Sanwang; Mu, Lingli; Yu, Peng

Tang, Fang; Zhou, Rui; Cheng, Zeneng; Yang, Guoping; Chen, Aiqiao; Liu, Zhi; Tan, Hongyi; Yang, Shuang; Li, Sanwang; Mu, Lingli; Yu, Peng.

Afiliação

Tang F; School of Pharmaceutical Sciences, Central South University, Changsha 410013, China.
Zhou R; School of Pharmaceutical Sciences, Central South University, Changsha 410013, China.
Cheng Z; School of Pharmaceutical Sciences, Central South University, Changsha 410013, China.
Yang G; The Third Xiangya Hospital, Central South University, Changsha 410013, China.
Chen A; School of Pharmaceutical Sciences, Central South University, Changsha 410013, China; Hunan Tiger-Xiangya R&D Company Ltd., Changsha 410013, China.
Liu Z; Hunan Tiger-Xiangya R&D Company Ltd., Changsha 410013, China.
Tan H; The Third Xiangya Hospital, Central South University, Changsha 410013, China.
Yang S; The Third Xiangya Hospital, Central South University, Changsha 410013, China.
Li S; School of Pharmaceutical Sciences, Central South University, Changsha 410013, China.
Mu L; Medical College, Hunan Normal University, Changsha 410006, China.
Yu P; School of Pharmaceutical Sciences, Central South University, Changsha 410013, China.

Acta Pharm Sin B ; 6(1): 71-8, 2016 Jan.

Article em En | MEDLINE | ID: mdl-26904401

Palavras-chave

3-Hydroxy-agomelatine; 7-Desmethyl-agomelatine; Agomelatine; Chinese subjects; Generic drug; High variability; Reference-scaled average bioequivalence

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Idioma: En Revista: Acta Pharm Sin B Ano de publicação: 2016 Tipo de documento: Article

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