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Sampling times and genotyping concerns in bioequivalence evaluation of branded and generic formulations

Authors Zhao X, Xu H, Zhou Q 

Received 17 September 2013

Accepted for publication 19 September 2013

Published 25 November 2013 Volume 2013:9 Pages 463—468


Checked for plagiarism Yes

Xiao-Ying Zhao,1 Hui-Min Xu,2 Quan Zhou2

1The Medical Ethics Committee, 2Department of Pharmacy, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, People's Republic of China

We read with great interest the study by Del Tacca et al,1 who performed a comparative pharmacokinetic (PK) and pharmacodynamic (PD) evaluation of branded and generic formulations of meloxicam in healthy male subjects, and concluded that the two products can be used interchangeably in clinical practice. We especially appreciate their exploratory study on the PD/PK relationship which provides an important reference for bioequivalence studies of analgesics. However, we found two points worthy of discussion and we would like to share our perspectives in the following paragraphs.

View original paper by Del Tacca and colleagues.

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