Publications by authors named "Golob M"

Laparoscopic distal pancreatectomy is a minimally invasive approach for the surgical treatment of neoplasms in the distal pancreas. This study aimed to compare this approach to the open procedure. A retrospective analysis of a prospectively maintained database of 400 pancreatectomies was performed.

View Article and Find Full Text PDF

Currently there is no detailed, internationally agreed protocol defined to evaluate antimicrobial susceptibility testing (AST) for Legionella pneumophila (required to establish epidemiological cut-off value or "ECOFF" boundaries); therefore, antimicrobial resistance in these isolates cannot be defined. AST methods utilising media containing activated charcoal as an ingredient, to enable Legionella growth, are unreliable as noted in an internationally authored opinion paper and a new gold standard is required. Here we define a detailed protocol for broth microdilution (BMD) using defined cell culture collection-deposited control reference strains (Philadelphia-1 and Knoxville-1) as well as two accessible reference strains with moderately (lpeAB-carrying) and markedly (23S rRNA mutation-carrying) elevated azithromycin minimum inhibitory concentration (MIC).

View Article and Find Full Text PDF

Montenegrin Digital Academic Innovation Hub established within Erasmus+ project DigNEST is essential institutional support for developing innovations in the field of health in academic-business cooperation and partnership. Experience of 18 months in running Hub service provides preliminary results in analysis received innovation ideas, provided support and potentials/capacities in medical informatics advancements at national, regional and global level.

View Article and Find Full Text PDF
Article Synopsis
  • Immunogenicity guidance in the biopharmaceutical industry has evolved significantly over the past 20 years due to initial negative reactions with erythropoietin, leading to stringent practices for all biotherapeutic drugs.
  • A recent workshop by the European Bioanalysis Forum highlighted the need to reassess current immunogenicity testing methods, drawing from two decades of experience to suggest more relevant approaches.
  • The proposed new paradigm encourages a context-based assessment of immunogenicity risk, viewing it as a pharmacodynamic biomarker, which aims to streamline testing strategies and better allocate resources for patient benefit.
View Article and Find Full Text PDF

The European Bioanalysis Forum, in collaboration with several key industry stakeholders, has recently led discussions that address international immunogenicity guidance documents, specifically the three tier approach for immunogenicity testing strategies, after more than 20 years of experience with biotherapeutics. As part of this, the strategy and methods used to assess drug tolerance across all immunogenicity assays are challenged, emphasizing that bioanalytical scientists need to consider the context-of-use of each assay. Here, recommendations for drug tolerance assessments, driven by strong scientific rationale and subject to reevaluation as needed, are provided.

View Article and Find Full Text PDF

The European Bioanalysis Forum, alongside key industry stakeholders, has been driving the discussions around the implementation of context-of use for biomarker assays to ensure that these assays are validated appropriately depending on their purpose. Insights into understanding why the implementation of context-of-use in assay strategies has also shown that the key stakeholder, or requester for the biomarker data, is responsible for providing the context-of-use statement for all biomarker assay requests. Experts from across the industry haves repeatedly sought a cross-industry recommended format in which the context-of-use statement could be provided.

View Article and Find Full Text PDF

Primary angiitis of the central nervous system (PACNS) is a rare and severe disease confined to the central nervous system, i.e., the brain and spinal cord.

View Article and Find Full Text PDF
Article Synopsis
  • * To address these ambiguities, the European Bioanalysis Forum held a workshop in November 2023 in Barcelona to discuss the problematic areas identified by their community and attendees.
  • * The manuscript reports the workshop outcomes and offers recommendations to foster ongoing dialogue between the industry and health authorities, promoting a science-driven approach to improve global harmonization in developing quality medicines.
View Article and Find Full Text PDF
Article Synopsis
  • Scientists created a special cell model called the MAGIC model to understand how bacteria live in the human mammary gland, which is important for health.
  • They used a type of cell called MCF10A that can grow similar to cells found in the mammary gland and tested how well bacteria from human milk can stick to this model.
  • The MAGIC model showed important details about how bacteria attach and react to different milk samples, which can help researchers learn more about bacterial interactions in the mammary gland.
View Article and Find Full Text PDF

Background And Aims: Standard approaches to smoking cessation may not be as effective for certain populations, and tailoring on cultural factors could improve their effectiveness. This systematic review measured the effectiveness of culturally tailoring smoking cessation interventions on quitting or reducing smoking combustible tobacco.

Method: We searched MEDLINE, PsychInfo, Embase and Cochrane Central Register from inception to 21 June 2023 for randomized controlled trials (RCTs) of community-based, primary care or web-based interventions for smoking cessation in adults who smoked tobacco, with measurement of smoking abstinence or reduction at least 3 months following baseline.

View Article and Find Full Text PDF

The potential risk to human and animal health provides a rationale for research on methicillin-resistant staphylococci (MRS) and mammaliicocci (MRM) in dairy herds. Here, we aimed to estimate their occurrence in the bulk tank milk (BTM) samples collected in 2019-2021 from 283 bovine dairy farms in the Belgrade district. We used whole-genome sequencing to characterize the obtained isolates and assess their genetic relatedness.

View Article and Find Full Text PDF

Rheumatoid arthritis (RA) is among the most prevalent and debilitating autoimmune inflammatory chronic diseases. Although it is primarily characterized by destructive peripheral arthritis, it is a systemic disease, and RA-related extraarticular manifestations (EAMs) can affect almost every organ, exhibit a multitude of clinical presentations, and can even be asymptomatic. Importantly, EAMs largely contribute to the quality of life and mortality of RA patients, particularly substantially increased risk of cardiovascular disease (CVD) which is the leading cause of death in RA patients.

View Article and Find Full Text PDF

In this report, the European Bioanalysis Forum shares the proposals for harmonized implementation of the ICH M10 guideline on bioanalytical method validation and study sample analysis from the ICH M10 workshop. The focus of the discussions was to understand new, changed or still ambiguous regulatory expectations in the guideline, as identified in feedback from the pre-workshop surveys or during the workshop. The proposals from the workshop aim at stimulating and helping a harmonized implementation of the guideline, and using our community as a sounding board during and after implementation to highlight areas of misalignment and to create a platform for continued sharing with the regulatory authorities in an effort to contribute to industry and regulators developing similar interpretations on guideline expectations.

View Article and Find Full Text PDF

Pigs were identified as the most important reservoir of livestock-associated methicillin-resistant (LA-MRSA), mostly belonging to the emergent zoonotic clonal complex (CC) 398. Here, we investigated the presence of MRSA in sows and piglets over a period of several months in two pig farms (intensive farm A and family-run farm B). Isolates underwent antimicrobial susceptibility testing, PCR characterization and typing.

View Article and Find Full Text PDF
Article Synopsis
  • Lactic acid bacteria (LAB) and bifidobacteria may harbor antimicrobial resistance (AMR), but the risk from strains used in food production is not well understood.
  • A study analyzing 474 strains found that intestinal isolates had higher rates of AMR compared to commercial strains, with 13.8% of commercial strains showing acquired resistance, mainly to tetracycline.
  • The research indicates that while intentional introduction of these bacteria into food doesn’t pose a major threat, caution is still needed with specific probiotic strains that may have a higher risk of transferring AMR in the gut.
View Article and Find Full Text PDF

Enterococci represent a significant part of the non-starter LAB microbiota of artisanal cheeses produced mainly from raw milk. Common approaches to safety evaluation of enterococci isolates include assessment of antimicrobial resistance and virulence potential. Hence, a collection of 47 (n = 22, Serbia; n = 25, Slovenia) dairy enterococcal isolates, of which (n = 28), (n = 11), (n = 5), (n = 2), and (n = 1), was analyzed.

View Article and Find Full Text PDF

Since 2011, the European Bioanalysis Forum has been discussing the topic of context-of-use for biomarker assays, in support of a cross-industry implementation of its principles. The discussions have led to the acknowledgement of the challenges that we face as an industry in implementing these principles. In addition to scientific recommendations, the European Bioanalysis Forum has addressed these challenges by providing recommendations on organizational design, and what works in both sponsor and contract research organizations, to support and enable context-of-use across biomarker strategies.

View Article and Find Full Text PDF

A 70% ethanol extract of the rhizome bark of the invasive alien plant species Japanese knotweed (JKRB) with potent (in the range of vitamin C) and stable antioxidant activity was incorporated in 1% into a chitosan biofoil, which was then characterized on a lab-scale. The 2,2-diphenyl-1-picrylhydrazyl (DPPH) assay confirmed the antioxidant activity of the JKRB biofoil upon contact with the food simulants A, B, C, and D1 (measured half-maximal inhibitory concentrations-IC) and supported the Folin-Ciocalteu assay result. The migration of the antioxidant marker, (-)-epicatechin, into all food simulants (A, B, C, D1, D2, and E) was quantified using liquid chromatography hyphenated to mass spectrometry (LC-MS).

View Article and Find Full Text PDF

Health and health systems are not excluded from the influence of digitalization. In Montenegro, regarding the digitization process, when compared to other sectors, the health sector is lagging. In this poster presentation, we present an ambitious Erasmus+ DigN€ST project aimed on modernization of digitalization of healthcare system in Montenegro, as one of priority fields at national level.

View Article and Find Full Text PDF

The spore-forming bacterium is the causative agent of American foulbrood (AFB), a devastating disease of honeybees (). In the present study, we used whole-genome sequencing (WGS) to investigate an extensive outbreak of AFB in northwestern Slovenia in 2019. A total of 59 .

View Article and Find Full Text PDF

is the causative agent of American foulbrood (AFB), a devastating disease of honeybees. spore counts in bee-related samples correlate with the presence of AFB symptoms and may, therefore, be used to identify at-risk colonies. Here, we constructed a TaqMan-based real-time PCR (qPCR) assay targeting a single-copy chromosomal metalloproteinase gene for reliable quantification of .

View Article and Find Full Text PDF

Antibiotics are frequently used for treating urinary tract infections (UTI) in dogs and cats. UTI often requires time-consuming and expensive antimicrobial susceptibility testing (AST). Alternatively, clinicians can employ Flexicult Vet, an affordable chromogenic agar with added antibiotics for in-clinic AST.

View Article and Find Full Text PDF

During the first half of 2021, and due to the SARS-CoV-2 pandemic preventing in-person meetings, the European Bioanalysis Forum organized four workshops as live interactive online meetings. The themes discussed at the workshops were carefully selected to match the cyberspace dynamics of the meeting format. The first workshop was a training day on challenges related to immunogenicity.

View Article and Find Full Text PDF

The insufficient quality of products containing beneficial live bacteria in terms of content and viability of labelled microorganisms is an often-reported problem. The aim of this work was to evaluate the quality of dietary supplements containing viable bacteria available in Slovenian pharmacies using plate counting, matrix-assisted laser desorption ionisation time-of-flight mass spectrometry (MALDI-TOF MS) and species- or subspecies-specific PCR with DNA isolated from consortia of viable bacteria, from individual isolates, or directly from the products. Twelve percent of the products (3 of 26) contained insufficient numbers of viable bacteria.

View Article and Find Full Text PDF