Biowaiver as a Bioequivalence Study Option

SCIENTIFIC RELEVANCE. Biowaiver is a procedure for establishing the bioequivalence of generic and reference products without in vivo studies. Regulatory requirements for this procedure, as described in a variety of documents, differ in certain features and aspects. These differences need to be analy...

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Bibliographic Details
Main Authors: E. A. Volkova, Yu. V. Medvedev, E. N. Fisher, I. E. Shohin
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2024-02-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
Online Access:https://www.vedomostincesmp.ru/jour/article/view/569