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No. 2 (2017)

NEW MEDICINES

Population pharmacokinetic modeling as a justification of practical application mode of paliperidone palmitate injectable in three-month formulation

https://doi.org/10.21265/PSYPH.2017.41.6438

Published 2017-03-30

  • E.V. Oleneva
    • ,
  • P.V. Ryvkin
    • ,
  • M.Ya. Ladyzhensky

E.V. Oleneva
Moscow Research Institute of Psychiatry - Branch of the V.P. Serbsky National Medical Research Center of Psychiatry and Narcology of the Ministry of Health of the Russian Federation

P.V. Ryvkin
Federal Medical Research Centre for Psychiatry and Narcology by the name of V.P. Serbsky Minzdrava RF

M.Ya. Ladyzhensky
Federal Medical Research Centre for Psychiatry and Narcology by the name of V.P. Serbsky Minzdrava RF

Abstract

SUMMARY: In article a series the pharmakokinentic aspects of practical use of a paliperidone palmitate injectable in threeBmonth formulation (PPI3M) both based on results of clinical tests,
and formulated as a result of the subsequent pharmacokinetic modeling are surveyed. The final population pharmakokinetic model of PPI3M was developed with data obtained from two clinical
trials for the purpose of the description of a pharmacokinetic profile of a paliperidon after PPI3M injection. References on renewal of therapy in cases of admissions of injections of different
duration are formulated, different schemes of transition from one dosage form of a paliperidon on another are discussed, and preferable dosage in special populations is defined. The most
important results of the clinical trials of PPI3M with pharmakokinetic studying have been reviewed.

Keywords

schizophrenia, paliperidone palmitate injectable in three-month formulation, population pharmacokinetic modeling

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