‘Identification. Peptide mapping’ is a necessary part of manufacturers’ product specification files for therapeutic proteins (active ingredients and final products of monoclonal antibodies, filgrastims, erythropoietins). The expert of the Federal State Budgetary Institu...

The article describes specific aspects of biosimilars research and development. The aim of the study was to analyse the ways to conduct comparative studies of biotechnological medicinal products and the main approaches to the assessment of the obtained data. The paper h...

The review compares individual case safety reports (ICSRs) for hydroxychloroquine, favipiravir, and the lopinavir/ ritonavir combination registered in the VigiBase global database during 6 months in 2019 and the same period in 2020 which coincides with the global “first...

The need for development of a clinical trial guidance for medicines for bronchial asthma is brought about by the improvement of requirements for research programmmes for new medicines. The aim of the study was to develop a methodological approach to conducting clinical ...

Open borders of the present-day pharmaceutical market call for improvement and harmonisation of the legal basis underlying drug circulation. Part of the overall process of harmonisation of regulatory requirements is the alignment of the terminological systems used in Ru...

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 u...

In order to harmonise national and foreign requirements for quality control of medicinal products, a second variant of the test method, which complies with the requirements of the European Pharmacopoeia, was included into the general monograph OFS.1.2.4.0008.18 “Test fo...

Until now, there have been no effective treatments for some ophthalmic diseases that have high social significance. Development of therapeutic approaches to such diseases may be complicated due to challenges in diagnosis and selection of clinical trial endpoints. The ai...

The article provides the results of a comparative analysis of requirements laid out in the State Pharmacopoeia of the USSR, XI ed. (SPh XI) and the State Pharmacopoeia of the Russian Federation, XIII ed. (SPh XIII) concerning quality evaluation and standardization of he...

The relevance of this study stems from the need for alignment of test methods used for identification and assay of anthracene derivatives in herbal preparations and herbal medicinal products. The aim of the study was to analyse Russian and international quality standard...