Neugodova N.P., Stepanyuk E.O., Sapozhnikova G.A., Sakanyan E.I., Ryabtseva M.S. Current approaches to the abnormal toxicity test. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya = The Bulletin of the Scientific Centre for Expert Evaluation of M...

‘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...

“Glycan Profile” is a necessary part of manufacturers’ product specification files for monoclonal antibody active ingredients or final products and erythropoietin active ingredients. The expert of the Federal State Budgetary Institution “Scientific Centre for Expert Eva...

Infectious process is an important cause of morbidity and mortality among patients with chronic kidney disease. Prescription of antibacterial drugs should take into account the pharmacokinetic parameters of the medicine and the individual characteristics of the patient....

The article dwells upon the development and implementation of a computerised information system for automation of expert work related to evaluation of medicines interchangeability parameters. The article analyses the results of application of a process-oriented approach...

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 article describes the main stages of introduction of the Good Distribution Practice (GDP) in Russia following the adoption of new laws making it mandatory for wholesalers to comply with requirements for storage and transportation of medicinal products. The article c...

Expansion of the range of new medicines leads to a significant increase in healthcare spending and, consequently, to the appearance of more affordable generic drugs. A drug can be recognised as generic if there is sufficient evidence of equivalent structural characteris...

The efficacy and safety of purine receptor agonists in patients with chronic pain have been analysed. The data on the clinical application of purine analgesia in the management of pain syndrome are reviewed. The use of purine analgesia for the treatment of patients with...

The article investigates the applicability of the amino column XBridge Amide 150×4.6 mm for separation of 4-hydroxybenzoic acid esters (parabens) — based on experience with hydrophilic interaction liquid chromatography used for analysis of various compounds. The study a...