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Investigation Planning and Bioequivalence evaluation of Angiotensin II Receptor Antagonists

  • D. P. RomodanovskiiEmail author
  • D. V. Goryachev
  • A. L. Khokhlov
  • A. N. Miroshnikov
Article
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Results of a retrospective analysis of bioequivalence studies of generic angiotensin II receptor antagonists are presented. Losartan, valsartan, and telmisartan medicines can be considered highly variable with respect to the pharmacokinetic parameter for maximum blood-plasma concentration. Candesartan, irbesartan, and olmesartan medicines do not demonstrate high intra-individual variance in bioequivalence studies. Current regulatory recommendations and approaches to bioequivalence studies of highly variable medicines are discussed. Recommendations for the design and evaluation of test results of angiotensin II receptor antagonists are formulated.

Keywords

bioequivalence intra-individual variance angiotensin II receptor antagonists 

Notes

Acknowledgments

The work was performed in the framework of a state task to SCEEMP, Ministry of Health of Russia, No. 056-00154-19-00 for applied scientific research (State Account No. NIR AAA-A18-118021590049-0).

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  • D. P. Romodanovskii
    • 1
    Email author
  • D. V. Goryachev
    • 1
  • A. L. Khokhlov
    • 2
  • A. N. Miroshnikov
    • 2
  1. 1.Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian FederationMoscowRussia
  2. 2.Yaroslavl State Medical University, Ministry of Health of the Russian FederationYaroslavlRussia

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