publication . Article . Other literature type . 2018

PRINCIPLES OF STATISTICAL EVALUATION OF BIOEQUIVALENCE STUDIES IN THE CONTEXT OF CURRENT REGULATORY REQUIREMENTS AND LEGAL ACTS

Romodanovsky, D. P.; Goryachev, D. V.; Solovieva, A. P.; Eremenko, N. N.;
Open Access Russian
  • Published: 22 Jun 2018 Journal: Ведомости Научного центра экспертизы средств медицинского применения, volume 8, issue 2, pages 92-98 (issn: 1991-2919, eissn: 2619-1172, Copyright policy)
  • Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”
Abstract
The article analyses regulatory documents and requirements for statistical principles of planning and evaluation of results of bioequivalence studies. It describes current statistical approaches to bioequivalence evaluation and relevant recommendations for the planning of studies of conventional medicinal products, medicinal products with a narrow therapeutic range, and analogues of endogenous compounds. The article analyses such statistical approaches as average Bioequivalence (ABE), Average Bioequivalence with Expanding Limits (ABEL), Reference-Scaled Average Bioequivalence (RSABE). It describes specific aspects of statistical analysis of insufficiently studie...
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free text keywords: bioequivalence study, statistical models, intra-individual variability, highly variable medicinal products, medicinal products with a narrow therapeutic range, endogenous compounds, pharmacokinetics, lcsh:Medicine (General), lcsh:R5-920, Type I and type II errors, Bioequivalence study, Multiple comparisons problem, Computer science, Bioequivalence, Statistical analysis, Statistical model, Econometrics
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