Investigation Planning and Bioequivalence evaluation of Angiotensin II Receptor Antagonists
- Authors: Romodanovskii D.P.1, Goryachev D.V.1, Khokhlov A.L.2, Miroshnikov A.N.2
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Affiliations:
- Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
- Yaroslavl State Medical University, Ministry of Health of the Russian Federation
- Issue: Vol 53, No 8 (2019)
- Pages: 680-684
- Section: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/245944
- DOI: https://doi.org/10.1007/s11094-019-02062-4
- ID: 245944
Cite item
Abstract
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.
About the authors
D. P. Romodanovskii
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Author for correspondence.
Email: Romodanovsky@expmed.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051
D. V. Goryachev
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: Romodanovsky@expmed.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051
A. L. Khokhlov
Yaroslavl State Medical University, Ministry of Health of the Russian Federation
Email: Romodanovsky@expmed.ru
Russian Federation, 5 Revolyutsionnaya St., Yaroslavl, 150000
A. N. Miroshnikov
Yaroslavl State Medical University, Ministry of Health of the Russian Federation
Email: Romodanovsky@expmed.ru
Russian Federation, 5 Revolyutsionnaya St., Yaroslavl, 150000