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

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

The aim of this study was to apply the reference-scaled average bioequivalence (RSABE) approach to evaluate the bioequivalence of 2 formulations of agomelatine, and to investigate the pharmacokinetic properties of agomelatine in Chinese healthy male subjects. This was performed in a single-dose, ran...

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Bibliographic Details
Main Authors: Fang Tang, Rui Zhou, Zeneng Cheng, Guoping Yang, Aiqiao Chen, Zhi Liu, Hongyi Tan, Shuang Yang, Sanwang Li, Lingli Mu, Peng Yu
Format: Article
Language:English
Published: Elsevier 2016-01-01
Series:Acta Pharmaceutica Sinica B
Subjects:
Reference-scaled average bioequivalence
Agomelatine
3-Hydroxy-agomelatine
7-Desmethyl-agomelatine
Chinese subjects
High variability
Generic drug
Online Access:http://www.sciencedirect.com/science/article/pii/S2211383515001446

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