A platform immunoassay for the quantification of biotherapeutics with glycine-serine linkers.

Assessing the pharmacokinetics of biotherapeutics is essential across all phases of drug development to understand drug exposure. At early stages, platform drug quantification immunoassays offer a versatile method for evaluating exposure for diverse biotherapeutics when specific reagents are not yet available, providing fast data for molecules with common structural features. To ensure clearly defined bioanalytical data, it is essential to conduct interference testing for anti-drug antibodies (ADA) or soluble target (starget), although these assays measure total exposure.

Early combination therapy with SGLT2i and GLP-1 RA or dual GIP/GLP-1 RA in type 2 diabetes.

Sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-Like peptide-1 receptor agonists (GLP-1 RA) are recommended in people with type 2 diabetes (T2D) for glycaemic control and for people with high cardiovascular risk. However, current guidelines do not specifically address the role of initial early combination therapy with SGLT2i and GLP-1 RA or dual gastric inhibitory polypeptide (GIP)/GLP-1 RA, but rather sequential initiation with either in T2D. This review synthesizes the available evidence on the use of SGLT2i and GLP-1-based therapies for T2D and provides a rationale for their combination.

Gritty Parenting: The Development and Validation of the Parental Grit Scale.

In this study, we aimed to expand the domain specificity of grit by exploring it in the realm of parenting. Parental grit was defined as parents' inclination to demonstrate perseverance, sustained passion, and adaptability in pursuing long-term parenting goals. With longitudinal data from 1,373 U.

Perspective on LC-MS(/MS) for biotherapeutic and biomarker proteins in research and regulated Bioanalysis: a consolidation of more than a decade of experience across the European Bioanalysis Forum community (Part 1: "The What").

Following up on our most recent discussion paper focusing on the continued regulatory challenges for bioanalysis of biotherapeutic and biomarker proteins with LC-MS/MS, the European Bioanalysis Forum reports back on their internal discussions on and experience with method development for biotherapeutic and biomarker proteins in research and regulated bioanalysis. Due to the broad array of topics discussed, this information is spread over two research papers, where one focusses on the fundamental principles on which the technology is built (i.e.

Chemotherapy Enriches for Proinflammatory Macrophage Phenotypes that Support Cancer Stem-Like Cells and Disease Progression in Ovarian Cancer.

High-grade serous ovarian cancer remains a poorly understood disease with a high mortality rate. Although most patients respond to cytotoxic therapies, a majority will experience recurrence. This may be due to a minority of drug-resistant cancer stem-like cells (CSC) that survive chemotherapy and are capable of repopulating heterogeneous tumors.

Weight Loss Pharmacotherapy: Current and Future Therapies.

The rising prevalence of obesity is of major concern. There are currently 5 Food and Drug Administration-approved medications for the treatment of obesity: orlistat, phentermine/topiramate, naltrexone/bupropion, liraglutide 3.0 mg, and semaglutide 2.

A 27-country test of communicating the scientific consensus on climate change.

Communicating the scientific consensus that human-caused climate change is real increases climate change beliefs, worry and support for public action in the United States. In this preregistered experiment, we tested two scientific consensus messages, a classic message on the reality of human-caused climate change and an updated message additionally emphasizing scientific agreement that climate change is a crisis. Across online convenience samples from 27 countries (n = 10,527), the classic message substantially reduces misperceptions (d = 0.

Assessing surface water quality in Hungary's Danube basin using geochemical modeling, multivariate analysis, irrigation indices, and Monte Carlo simulation.

Evaluation of water quality is crucial for managing surface water effectively, ensuring its suitability for human use, and sustaining the environment. In the lower Danube River basin, various methods were employed to assess surface water quality for irrigation, drinking, human health risk purposes and the main mechanism control the surface water chemistry. These methods included water quality indicators (WQIs), complex statistical analyses, geographic information systems (GIS), Monte Carlo simulation, and geochemical modeling.

The AusTraits plant dictionary.

Traits with intuitive names, a clear scope and explicit description are essential for all trait databases. The lack of unified, comprehensive, and machine-readable plant trait definitions limits the utility of trait databases, including reanalysis of data from a single database, or analyses that integrate data across multiple databases. Both can only occur if researchers are confident the trait concepts are consistent within and across sources.

Biodistribution of Drug/ADA Complexes: The Impact of Immune Complex Formation on Antibody Distribution.

The clinical use of therapeutic monoclonal antibodies (mAbs) for the treatment of cancer, inflammation, and other indications has been successfully established. A critical aspect of drug-antibody pharmacokinetics is immunogenicity, which triggers an immune response via an anti-drug antibody (ADA) and forms drug/ADA immune complexes (ICs). As a consequence, there may be a reduced efficacy upon neutralization by ADA or an accelerated drug clearance.

Spatial analysis of 10-year predicted risk and incident atherosclerotic cardiovascular disease: the CoLaus cohort.

Whether cardiovascular risk scores geographically aggregate and inform on spatial development of atherosclerotic cardiovascular diseases (ASCVD) remains unknown. Our aim is to determine the spatial distribution of 10-year predicted cardiovascular risk and ASCVD, and to compare the overlap of the resulting spatial distributions. Using prospective data from the CoLaus|PsyCoLaus cohort study (2003-2021) we computed SCORE2 in participants free from ASCVD.

Personal Recovery Among People at Risk for Developing Serious Mental Health Problems: A Qualitative Systematic Review.

Objective: Personal recovery refers to a person's pursuit of a full, meaningful life despite the potentially debilitating impact of a mental illness. An evidence base describing personal recovery among people at risk for developing a mental illness is lacking, limiting the potential for mental health services to support personal recovery. To address this gap, the authors synthesized the extant research describing personal recovery among people at risk for developing a mental illness.

Automated system for training and assessing reaching and grasping behaviors in rodents.

Background: Reaching, grasping, and pulling behaviors are studied across species to investigate motor control and problem solving. String pulling is a distinct reaching and grasping behavior that is rapidly learned, requires bimanual coordination, is ethologically grounded, and has been applied across species and disease conditions.

New Method: Here we describe the PANDA system (Pulling And Neural Data Analysis), a hardware and software system that integrates a continuous string loop connected to a rotary encoder, feeder, microcontroller, high-speed camera, and analysis software for the assessment and training of reaching, grasping, and pulling behaviors and synchronization with neural data.

Investigating the impacts of heavy metal(loid)s on ecology and human health in the lower basin of Hungary's Danube River: A Python and Monte Carlo simulation-based study.

This study aimed to determine the environmental and health risks of the heavy metal levels in the Danube River in Hungary. The metals, including Fe, Mn, Zn, Cu, Ni, Cr, Pb, and As, were measured in the period from 2013 to 2019. The Spearman correlation and heatmap cluster analysis were utilized to determine the origin of pollution and the factors that control surface water quality.

State of the Art of Participatory and User-led Research in Mental Health in Brazil: A Scoping Review.

Background: Participatory research denotes the engagement and meaningful involvement of the community of interest across multiple stages of investigation, from design to data collection, analysis, and publication. Traditionally, people with first-hand experience of psychiatric diagnoses, services users and those living with a psychosocial disability have been seen objects rather than agents of research and knowledge production. This, despite the ethical and practical benefits of their involvement.

Distinctive Arbutin-Containing Markers: Chemotaxonomic Significance and Insights into the Evolution of Proteaceae Phytochemistry.

Natural products isolation studies of eight endemic Tasmanian Proteaceae species - Agastachys odorata, Persoonia juniperina, Hakea megadenia, Hakea epiglottis, Orites diversifolius, Orites acicularis, Orites revolutus, and Telopea truncata - and three endemic Australian Proteaceae species Banksia serrata, Banksia praemorsa, and Banksia marginata were undertaken. Two previously unreported glycoside-derived natural products were identified, in addition to four other tremendously rare arbutin esters. The results of this study provide further evidence consistent with the proposal that these distinctive arbutin esters represent markers that can provide valuable insights into the chemical evolution of plant species within the family Proteaceae.

2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.

The 16 Workshop on Recent Issues in Bioanalysis (16 WRIB) took place in Atlanta, GA, USA on September 26-30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 16 WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.