A5080518102- Biosimilars and Bioanalytical Methods
- SARS-CoV-2 and COVID-19 Research
- Pharmaceutical studies and practices
- Vaccine Coverage and Hesitancy
- Hepatitis C virus research
- Multiple Sclerosis Research Studies
- Healthcare Systems and Public Health
- Rheumatoid Arthritis Research and Therapies
- COVID-19 Impact on Reproduction
- Hepatitis B Virus Studies
- Heparin-Induced Thrombocytopenia and Thrombosis
- Quality and Safety in Healthcare
- Urological Disorders and Treatments
- Monoclonal and Polyclonal Antibodies Research
- Human Health and Disease
- Tuberculosis Research and Epidemiology
- Hepatitis Viruses Studies and Epidemiology
- Pneumonia and Respiratory Infections
- Peripheral Neuropathies and Disorders
- Bacterial Infections and Vaccines
- Pharmaceutical Economics and Policy
University of Bologna
2023-2025
Saratov State Medical University
2017
Background: The advent of biosimilars has revolutionized the management conditions like rheumatoid arthritis by offering cost-effective alternatives to expensive biologics. Objectives: This study aims compare post-marketing safety profiles used in rheumatology with their respective reference products (RPs). Methods: Data were retrieved from EudraVigilance for adalimumab, etanercept, infliximab, and rituximab, compared RPs. Our analysis focused on authorized before 2021, using data January...
Biological drugs have improved the management of immune-mediated inflammatory diseases (IMIDs) despite being associated with important safety issues such as immunogenicity, infections, and malignancies in real-world settings.The aim this study was to explore potential a large Italian multi-database distributed network for use postmarketing surveillance biological drugs, including biosimilars, patients IMID.A retrospective cohort conducted using 13 regional claims databases during 2010-2019....
The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor COVID-19 through Covid-19 Vaccine Monitor (CVM) EudraVigilance surveillance systems published pivotal clinical trials.In a prospective cohort vaccinees aged between 5 17 years, measured frequency commonly reported (local/systemic solicited) serious adverse drug events (ADRs) following first second...
In the last decades, clinical management of oncology patients has been transformed by introduction biologics. The high costs associated with development and production biologics limit patient access to these therapies. expiration exclusive patents for led market biosimilars, offering reduction cancer treatments. Biosimilars are highly similar reference products in terms structure, biological activity, efficacy, safety, immunogenicity. Therefore, monitoring biosimilars’ safety real-world...
Abstract Aim To provide further evidence on the safety profile of COVID‐19 vaccines in paediatrics by analysing spontaneous reports adverse effects related to these vaccines. Methods Reports US paediatric population (from 0 17 years) vaccinated with authorised were extracted from Vaccine Adverse Event Reporting System December 2020 November 2022. We conducted a descriptive analysis Events Following Immunization (AEFI), calculating reporting rate serious AEFIs and focusing myocarditis...
Objective: Study of the prevalence viral hepatitis C and B in territory Saratov City Region, analysis revealed cases discussion laboratory diagnostics issues. Methods: Statistical reporting forms were used CJSC «Doctor Paramonov’s Clinic» City, immunoenzyme method testing blood serum which identify antibodies antigens, statistical analysis. Results: Analysis received data shows increasing number persons, who tested for B. A tendency annual increase infected among persons are observed....