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Long-acting formulations delivering aripiprazole: beyond single-value characterizations of steady-state pharmacokinetics

Authors McConnell SA, Desai DN, Faldu SP, Hard ML, Wehr AY, Weiden PJ, von Moltke L

Received 6 June 2017

Accepted for publication 7 June 2017

Published 12 July 2017 Volume 2017:13 Pages 1815—1816


Checked for plagiarism Yes

Editor who approved publication: Dr Roger Pinder

Scott A McConnell,1 Dharmik N Desai,1 Sejal P Faldu,1 Marjie L Hard,2 Angela Y Wehr,3 Peter J Weiden,1 Lisa von Moltke3

1Medical Affairs, Alkermes, Inc., Waltham, MA, 2Nuventra Pharma Sciences, Durham, NC, 3Clinical Research, Alkermes, Inc., Waltham, MA, USA

The recent publication by Salzman et al1 compared pharmacokinetic (PK) data from population PK (popPK) models for two long-acting antipsychotic formulations: aripiprazole once-monthly 400 mg (AOM 400) and aripiprazole lauroxil (AL). We would like to address a few major concerns. The AL popPK model has been well described in a peer-reviewed publication.2 However, Salzman et al omitted publishing information regarding the development and validation of the AOM popPK model, including any critical discussion of the covariates, other key characteristics, assumptions and limitations of the AOM model. Thus, a reader cannot objectively assess the simulated values for AOM reported in the publication.

View the original paper by Salzman and colleagues.

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