Comparative analysis of physicochemical properties, bioequivalence, safety and tolerability of the first domestic semaglutide [PDF]
Semaglutide is a representative of analogues of the incretin hormone human glucagon-like peptide-1 (GLP-1) and is currently used in Russia for the treatment of type 2 diabetes mellitus (T2DM; in monotherapy and in combination therapy), including patients
A. S. Ametov +17 more
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Problems of bioanalytical part of bioequivalence studies of drugs in Russia
Фармакокинетика и Фармакодинамика, 2014 In the review of the main problems holding bioanalytical part of bioequivalence studies of medicines in Russia. The analysis of the major causes of failure when performing studies of bioequivalence and pharmacokinetics.
A. L. Khokhlov +5 more
doaj
Interchangeability of levothyroxine sodium tablets
Регуляторные исследования и экспертиза лекарственных средств, 2018 The article reviews scientific literature and regulatory documents on safe and efficacious use of levothyroxine medicines. Levothyroxine has less than a twofold difference between the minimal toxic concentration and minimal effective concentration.
G. I. Gorodetskaya +5 more
doaj
Interchangeability of glibenclamide-containing drugs
Регуляторные исследования и экспертиза лекарственных средств, 2018 The article analyses the problem of interchangeability of glibenclamide-containing drugs that sometimes lack therapeutic equivalence even though their bioequivalence has been proven.
G. I. Gorodetskaya +8 more
doaj
Регуляторные исследования и экспертиза лекарственных средств, 2018 Perindopril is a prodrug which is converted to an active metabolite perindoprilat in the human organism. The present study led to the development of a fast and easily reproducible procedure for simultaneous detection of perinoprilat and its metabolite in
L. M. Krasnykh +5 more
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Recommendations on the procedure for determining the interchangeability of medicinal products
Регуляторные исследования и экспертиза лекарственных средств, 2018 The authors developed and presented recommendations on the procedure for determining the interchangeability of medicinal products. Interchangeability of drugs determined at the state registration of the medicinal product or when amendments to the ...
B. K. Romanov +12 more
doaj
Peculiarities of approaches to assessing the interchangeability of antiepileptic drugs
Безопасность и риск фармакотерапии, 2018 The adequacy of the interchangeability of original and generic drugs is an important economic and social problem in healthcare. In this article we look at the problem of the replacement of antiepileptic drugs.
E. O. Zhuravleva +2 more
doaj
On the interchangeability of calcineurine inhibitors
Безопасность и риск фармакотерапии, 2018 Calcineurin inhibitors, cyclosporine and tacrolimus, are the main immunosuppressants used in solid organ transplantation, but the peculiarities of their pharmacokinetics allow to classify them to a group of medicines with a narrow therapeutic range ...
K. E. Zatolochina +6 more
doaj
The interchangeability of drugs from line items of pharmaceutical compliance and clinical efficiency and safety [PDF]
, 2018 Questions of replacement of original medicines with generic are discussed. The sintesation of identical medicine is a complex challenge from the technological point of view.
D. Ya. Zhukova +4 more
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Проблемы проведения биоаналитической части исследований биоэквивалентности лекарственных препаратов в России [PDF]
, 2014 In the review of the main problems holding bioanalytical part of bioequivalence studies of medicines in Russia. The analysis of the major causes of failure when performing studies of bioequivalence and pharmacokinetics.В обзоре рассмотрены основные ...
A. L. Khokhlov +11 more
core +1 more source