publication . Article . Other literature type . 2018

Planning and Evaluation of Bioequivalence Studies of Enalapril Products

Romodanovsk, D. P.; Khokhlov, A. L.; Miroshnikov, A. E.;
Open Access
  • Published: 01 Dec 2018 Journal: The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products, volume 8, pages 231-237 (issn: 1991-2919, eissn: 2619-1172, Copyright policy)
  • Publisher: SCEEMP
Abstract
Nowadays retrospective analysis of bioequivalence studies of medicinal products that have the same International Nonproprietary Name is becoming particularly relevant. Over the past years we have accumulated a sufficient pool of data in the Russian Federation which make it possible to identify many differences, difficulties and errors associated with bioequivalence studies (especially those of highly variable drugs). Given that inhibitors of angiotensin-converting enzyme (ACE) can be highly variable, we conducted a retrospective analysis of bioequivalence studies of domestically-produced and foreign-made generic enalapril products. This article presents the resu...
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free text keywords: bioequivalence study, highly variable drugs, inhibitors of angiotensin-converting enzyme, Medicine, business.industry, business, Enalaprilat, medicine.drug, Pharmacology, Clinical study design, High variability, Blood sampling, Pharmacokinetics, Active metabolite, Bioequivalence, Enalapril, lcsh:Medicine (General), lcsh:R5-920
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