Investigation Planning and Bioequivalence evaluation of Angiotensin II Receptor Antagonists

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. Candesart...

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Bibliographic Details
Published inPharmaceutical chemistry journal Vol. 53; no. 8; pp. 680 - 684
Main Authors Romodanovskii, D. P., Goryachev, D. V., Khokhlov, A. L., Miroshnikov, A. N.
Format Journal Article
LanguageEnglish
Published New York Springer US 01.11.2019
Springer
Subjects
Angiotensin
Evaluation
Investigations
Medicine
Organic Chemistry
Pharmacology/Toxicology
Pharmacy
Telmisartan
Valsartan
intra-individual variance
bioequivalence
angiotensin II receptor antagonists
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Summary: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.
ISSN:0091-150X
1573-9031
DOI:10.1007/s11094-019-02062-4