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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| Published in | Pharmaceutical chemistry journal Vol. 53; no. 8; pp. 680 - 684 |
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| Main Authors | , , , |
| Format | Journal Article |
| Language | English |
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01.11.2019
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| 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. |
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| AbstractList | 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. |
| Audience | Academic |
| Author | Goryachev, D. V. Romodanovskii, D. P. Miroshnikov, A. N. Khokhlov, A. L. |
| Author_xml | – sequence: 1 givenname: D. P. surname: Romodanovskii fullname: Romodanovskii, D. P. email: Romodanovsky@expmed.ru organization: Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation – sequence: 2 givenname: D. V. surname: Goryachev fullname: Goryachev, D. V. organization: Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation – sequence: 3 givenname: A. L. surname: Khokhlov fullname: Khokhlov, A. L. organization: Yaroslavl State Medical University, Ministry of Health of the Russian Federation – sequence: 4 givenname: A. N. surname: Miroshnikov fullname: Miroshnikov, A. N. organization: Yaroslavl State Medical University, Ministry of Health of the Russian Federation |
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| Cites_doi | 10.12793/tcp.2015.23.2.49 10.5414/CP201991 10.12793/tcp.2018.26.1.6 10.1208/s12248-012-9406-x 10.2165/11318040-000000000-00000 10.1016/j.clinthera.2017.05.048 10.1007/s11095-016-2006-1 10.1208/s12248-008-9015-x 10.1002/pst.1816 |
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| References_xml | – start-page: 174 volume-title: Handbook for Drug Review [in Russian] year: 2013 ident: 2062_CR8 – ident: 2062_CR13 – ident: 2062_CR16 – ident: 2062_CR15 – volume: 23 start-page: 49 issue: 2 year: 2015 ident: 2062_CR12 publication-title: Transl. Clin. Pharmacol. doi: 10.12793/tcp.2015.23.2.49 contributor: fullname: J Lee – volume: 52 start-page: 64 issue: 1 year: 2014 ident: 2062_CR14 publication-title: Int. J. Clin. Pharmacol. Ther. doi: 10.5414/CP201991 contributor: fullname: C Jin – ident: 2062_CR7 – ident: 2062_CR6 – volume: 26 start-page: 06 issue: 1 year: 2018 ident: 2062_CR1 publication-title: Transl. Clin. Pharmacol. doi: 10.12793/tcp.2018.26.1.6 contributor: fullname: I Chung – volume: 14 start-page: 915 issue: 4 year: 2014 ident: 2062_CR11 publication-title: AAPS J. doi: 10.1208/s12248-012-9406-x contributor: fullname: BM Davit – volume: 48 start-page: 725 year: 2009 ident: 2062_CR4 publication-title: Clin. Pharmacokinet. doi: 10.2165/11318040-000000000-00000 contributor: fullname: L Tothfalusi – ident: 2062_CR2 doi: 10.1016/j.clinthera.2017.05.048 – volume: 4 start-page: 5 year: 2015 ident: 2062_CR5 publication-title: Vedom. NTsESMP contributor: fullname: DP Romodanovskii – volume: 33 start-page: 2805 year: 2016 ident: 2062_CR9 publication-title: Pharm. Res. doi: 10.1007/s11095-016-2006-1 contributor: fullname: D Labes – ident: 2062_CR10 doi: 10.1208/s12248-008-9015-x – volume: 16 start-page: 361 year: 2017 ident: 2062_CR3 publication-title: Pharm. Stat. doi: 10.1002/pst.1816 contributor: fullname: Q Kang |
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| SubjectTerms | Angiotensin Evaluation Investigations Medicine Organic Chemistry Pharmacology/Toxicology Pharmacy Telmisartan Valsartan |
| Title | Investigation Planning and Bioequivalence evaluation of Angiotensin II Receptor Antagonists |
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