publication . Article . 2019

Assessment of the Feasibility of Therapeutic Equivalence Studies

Goryachev, D. V.; Uvarova, N. E.;
Open Access Russian
  • Published: 05 Jun 2019 Journal: Ведомости Научного центра экспертизы средств медицинского применения, volume 9, issue 2, pages 79-84 (issn: 1991-2919, eissn: 2619-1172, Copyright policy)
  • Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”
Abstract
The introduction of the «therapeutic equivalence» concept into the Russian legislation is critical for evaluation of medicines interchangeability and for recognising them as generics. It is stipulated by the legislation that therapeutic equivalence has to be evaluated using a special instrument — «therapeutic equivalence study». The aim of this work was to analyse the validity of considering a therapeutic equivalence study as the only study that allows for confirmation of therapeutic equivalence of medicines. The term «therapeutic equivalence» has been adopted by the leading world regulators, but there is no clear concept of what is a therapeutic equivalence cli...
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free text keywords: therapeutic equivalence study, clinical trial, therapeutic equivalence, bioequivalence, statistical analysis, Medicine (General), R5-920, Therapeutic equivalence, Interchangeability, Legislation, Statistical analysis, Clinical trial, Bioequivalence, Risk analysis (engineering), Clinical study, Computer science
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