<jats:p>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 Evaluat...

<jats:p>Fluconazole – an antifungal agent belonging to the chemical class of triazole derivatives – is represented in the Russian pharmaceutical market by a large number of generic drugs. An important issue of rational pharmacotherapy is the demonstration of the referen...

<jats:p>There are no specific requirements and recommendations in the Russian Federation for evaluation of bioequivalence of modified-release medicinal products. Until recently, modified-release products were regulated in a similar manner as immediate-release products, ...

<jats:p> The use of assay methods with different test conditions for determination of anthracene derivatives in herbal substances and herbal medicinal products requires adjustment of the established limits for total anthracene derivatives content based on the test metho...

Nowadays retrospective analysis of bioequivalence studies of medicinal products that have the same International Nonproprietary Name is becoming particularly relevant. Over the past years we have accumulated a sufficient pool of data in the Russian Federation which make...

<jats:p>The process of harmonisation of Russian and foreign approaches and requirements in the field of medicines quality assurance calls for revision of quality control procedures included in various regulations and guidelines. The monograph FS.2.5.0062.18 “Hawthorn fl...

A high demand for sildenafil-based drugs puts a premium on the development of methods for quantitation of sildenafil in bio-substrates to facilitate pharmacokinetic analysis in bioequivalence studies. High performance liquid chromatography coupled with tandem mass spect...

<jats:p>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 globa...

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...

The article reviews literature data on development and clinical use of biomedical cell products (BCPs) — a new class of medicines which could be approved for distribution and use only after their specific activity and safety have been thoroughly examined at the stage of...