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

• Main Authors: Fang Tang (Author), Rui Zhou (Author), Zeneng Cheng (Author), Guoping Yang (Author), Aiqiao Chen (Author), Zhi Liu (Author), Hongyi Tan (Author), Shuang Yang (Author), Sanwang Li (Author), Lingli Mu (Author), Peng Yu (Author)
• Format: Book
• Published: Elsevier, 2016-01-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...