Objective: Evaluation of the lag timelines for the launch of innovative drugs to the Russian market and pharmacoeconomic factors they can depend on. Methods: To complete the investigation, we used information about drug products, namely, dates of submission and approval, and pharmacological groups recovered from national registers and official databases. Results: Due to impacts of market factors and imperfection of the state regulation, original drugs developed abroad enter the Russian market a few years after their registration in the United States of America, the European Union, and Japan. The average time from the moment of initial approval of a drug in the aforementioned countries and jurisdictions to the moment of registration in Russia is 4 years and 8 months, with a median value of 2.5 years. It has been shown that half of this term is spent on the performance of the procedures of the expertise of the drug registration dossier in the Russian Federation. Conclusion: To attain the goal of adequate supplies to the population of the Russian Federation of the most up-to-date, high quality, safe, and efficacious medications, apart from the support of national originators of innovative drugs, we are required to upgrade the existing system of original drug registration. Improvement should be primary focused on the drugs already approved by the leading national regulatory authorities in order to ensure innovative medicine access for Russian patients.

Background/Objectives: Pulmonary fibrosis (PF) results in a progressive decline of lung function due to scarring. Drugs are among the most common causes of PF. The objective of our study was to reveal the structure of drugs involved in PF development. Methods: we performed a retrospective descriptive pharmacoepidemiologic study on spontaneous reports (SRs) with data on PF registered in the Russian National Pharmacovigilance database for the period from 4 January 2019 to 31 May 2024. Results: A total of 1308 SRs on PF were finally identified with patients mean age of 59.3 ± 23.4 years. Death was reported in 30.7% (n = 401) with mean age of 59.9 ± 13.8 years. In the structure of culprit drugs, the following groups were leaders: antineoplastic and immunomodulating agents (51.9%); systemic hormonal preparations, excluding sex hormones and insulins (7.4%); drugs affecting nervous system (7.1%); respiratory system (7.1%); alimentary tract and metabolism (6.5%); and cardiovascular system (5.5%). In the total sample, the top ten drugs were rituximab (5.5%), methotrexate (4.4%), etanercept (4.2%), leflunomide (4.0%), adalimumab (3.7%), tocilizumab (3.3%), abatacept (3.0%), alendronic acid (2.7%), secukinumab (2.6%), and infliximab (2.4%). The number of SRs per year nearly doubled from 2021 to 2022 and from 2022 to 2023 with a maximum peak expected for 2024. Conclusions: Our study demonstrated increased reporting on PF in the National Pharmacovigilance database from 2019 to 2024. We revealed outstanding results for the role of antineoplastic and immunomodulating agents in PF development.

Background/Objectives: The advantages of medicines compounded in pharmacies are that they take into account the individual characteristics of the patient, the absorption characteristics of active pharmaceutical ingredients, the possibility of allergic reactions, the already taken medicines, and the adequacy of the dosage in relation to body weight. Compounding pharmacies allow meeting the needs in dosage forms that have no industrial analogues, ensure individual dosing of active pharmaceutical ingredients and dosage forms without preservatives and other non-indifferent additives. Methods: The impact of such factors as compounding under aseptic conditions, storage in a cool place at a temperature of 8-15°C, hermetically sealed packaging and capping conditions and the use of different solvents on the quality of the liquid dosage forms were studied. Statistical analysis used: All statistical procedures were performed using R (R Core Team, 2016). Results: It was found that during storage, the appearance of the liquid dosage forms according to all studied prescriptions did not change. The pH of the studied suspension changed only slightly during the 30-day storage period. In the freshly compounded dosage forms, all values of the quantitative content of the components in the prescriptions met the requirements, and the deviations were within the acceptable range. Conclusions: Thus, the studied prescriptions 1 and 2 can be stored for 20 days, while prescription 3 can be stored for 10 days at room temperature and 20 days in a cool place.

Introduction. About a quarter of the world's population suffers from helminthic invasion. Praziquantel is a drug for the treatment of helminthiasis caused by cestodes and trematodes. The development of generic drugs for the fight against helminthiasis in Russia seems to be relevant.The aim of the study was to compare the pharmacokinetics profiles of generic Praziquantel and Biltricid® (reference drug), to assess their safety during their bioequivalence study.Materials and methods. An open, randomized, crossover, four-period, replicative design study was conducted on 32 male healthy volunteers.Results. Similar pharmacokinetic profiles of praziquantel were found when volunteers took Praziquantel and Biltricid®. According to the analysis of variance, the main factors that make a significant contribution to the observed variability of the data were interindividual differences in volunteers and the sequence of taking drugs. 90% CI of the ratios of AUC0-t, AUC0-∞, and Cmax of the tested drug to the reference one were in the range of 80-125%. Praziquantel preparations have been found to have a satisfactory safety profile.