2024 White Paper on Recent Issues in Bioanalysis: Three Way-Cross Validation; Urine Clinical Analysis; Automated Methods; Regulatory Queries on Plasma Protein Binding; Automated Biospecimen Management; ELN Migration; Ultra-Sensitivity Mass Spectrometry ( - Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV).

The 18 Workshop on Recent Issues in Bioanalysis (18 WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18 WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

Evaluation of the evidence-based practices for the management of PCOS in the Latin America context: the consensus of the Latin American Association of Gynecological Endocrinology (ALEG).

Objectives: Polycystic Ovary Syndrome (PCOS) is a complex condition affecting approximately 1 in 10 women of reproductive age. However, limited data are available regarding the specific characteristics and needs of women with PCOS in Latin America. This consensus sought to evaluate the evidence-based practices for the management of PCOS for Latin American populations, consolidate regional insights, identify eventual gaps in implementation and identify key research opportunities.

Weighing up GnRH agonist therapy for endometriosis: outcomes and the treatment paradigm.

Introduction: Endometriosis is a chronic inflammatory estrogen-dependent disease affecting 10% of women worldwide leading to chronic pelvic pain and infertility which may be treated clinically or surgically.

Areas Covered: Current literaure was reviewed using the keywords 'gonadotropin releasing hormone agonists (GnRHa),' 'endometriosis,' 'infertility' and 'chronic pelvic pain.' Relevant papers prioritizing randomized controlled clinical trials (RCT), systematic reviews, meta-analyses, as well as international guidelines were evaluated.

Syndemic, mental health and living with dependent persons in Latin America and Spain: a study with a gender perspective.

Objective: To analyze the sociostructural determinants associated with mental health problems during the lockdown period among populations residing in Brazil, Chile, Ecuador, Mexico, Peru, and Spain who lived with minors or dependents, approached from a gender perspective.

Methods: A cross-sectional study was conducted in six participating countries via an adapted, self-managed online survey. People living with minors and/or dependents were selected.

Relationship between plasma urea and copeptin in response to arginine stimulation in healthy adults, patients with vasopressin deficiency and primary polydipsia.

Background: Arginine infusion stimulates copeptin secretion, a surrogate marker of arginine vasopressin (AVP), thereby serving as a diagnostic test in the differential diagnosis of suspected AVP deficiency (AVP-D). Yet, the precise mechanism underlying the stimulatory effect of arginine on the vasopressinergic system remains elusive. Arginine plays a significant role in the urea cycle and increases the production of urea.

Access to HIV testing and factors associated among sexual minority women in a metropolitan region of the Brazilian Amazon.

In Brazil, health policies implemented over the last three decades have enabled rapid testing for HIV to be made available in primary health care services. However, although these policies are national, the implementation of actions is not uniform, as they depend on the local management of local health systems. In this context, the study identified the proportion of women from sexual minorities who had never tested for HIV and the factors associated with access, in a Metropolitan Region of the Brazilian Amazon.

Osilodrostat improves blood pressure and glycemic control in patients with Cushing's disease: a pooled analysis of LINC 3 and LINC 4 studies.

Purpose: To evaluate the effect of osilodrostat and hypercortisolism control on blood pressure (BP) and glycemic control in patients with Cushing's disease.

Methods: Pooled analysis of two Phase III osilodrostat studies (LINC 3 and LINC 4), both comprising a 48-week core phase and an optional open-label extension. Changes from baseline in systolic and diastolic BP (SBP and DBP), fasting plasma glucose (FPG), and glycated hemoglobin (HbA) were evaluated during osilodrostat treatment in patients with/without hypertension or diabetes at baseline.

Versatility of Caenorhabditis elegans as a Model Organism for Evaluating Foodborne Neurotoxins and Food Bioactive Compounds in Nutritional Neuroscience.

Epidemiological evidence has shown that the regular ingestion of vegetables and fruits is associated with reduced risk of developing chronic diseases. The introduction of the 3Rs (replacement, reduction, and refinement) principle into animal experiments has led to the use of valid, cost-effective, and efficient alternative and complementary invertebrate animal models which are simpler and lower in the phylogenetic hierarchy. Caenorhabditis elegans (C.

Comparison of the diagnostic performance of non-contrast MR angiography and planar V/Q scintigraphy for pulmonary embolism: a systematic review and meta-analysis.

Objectives: To conduct a meta-analysis of the diagnostic performance of non-contrast magnetic resonance pulmonary angiography (NC-MRPA) and ventilation-perfusion (V/Q) scintigraphy for the detection of acute pulmonary embolism (PE).

Materials And Methods: Systematic searches of electronic databases were conducted from 2000 to 2024. Primary outcomes were per-patient sensitivity and specificity of NC-MRPA and V/Q scintigraphy.

Real World Evidence From 2 Decades of First-Line TKI Therapy in Chronic Myeloid Leukemia (CML): Insights From ACHO's RENEHOC Registry.

Background: Chronic myeloid leukemia (CML) treatment has significantly evolved with the introduction of tyrosine kinase inhibitors. However, access to these treatments and outcomes vary globally. This study examines 2 decades of CML management in Colombia using the RENEHOC registry, focusing on TKI efficacy, safety, and healthcare system challenges.

Validation of an automated quality control method to test sterility of two advanced therapy medicinal products: Mesenchymal stromal cells and their extracellular vesicles.

Mesenchymal stromal cells are multipotent cells present in various tissues that are widely studied for relevant therapeutic potential due to their paracrine immunomodulatory and tissue regenerating properties. Many mesenchymal stromal cell-based products are under investigation for the treatment of different clinical conditions. Recently, the therapeutic potential of the extracellular vesicles released by these cells has been under focus, with emphasis on clinical translation.

On the consequences of childbirth: obstetrics/gynaecology, comparative anatomy and racial theories in 19th century France and Brazil.

The following paper is centred on an analysis of comparative studies of the human pelvis developed over the 19th century by mostly French natural scientists, physical anthropologists, students of the human anatomy and doctors engaged in the initial stages of the emerging fields of gynaecology and obstetrics. As this paper will argue, there was considerable overlap between these specialisations, producing a fundamentally masculine, Eurocentric and racialised knowledge that had an enormous impact in establishing racially informed gynaecological and obstetric practices. This paper argues that comparative pelvic anatomy studies originated from the belief that African and Black women had specifically different pelves and genitalia and served to stratify women of different races and promoted racially oriented obstetric and gynaecological treatments.

Evaluating amyloid-beta aggregation and toxicity in transgenic Caenorhabditis elegans models of Alzheimer's disease.

Alzheimer's disease (AD) is the leading cause of dementia in the elderly, clinically characterized by memory loss, cognitive decline, and behavioral disturbances. Its pathogenesis is not fully comprehended but involves intracellular depositions of amyloid beta peptide (Aβ) and neurofibrillary tangles of hyperphosphorylated tau. Currently, pharmacological interventions solely slow the progression of symptoms.

Evaluating polyglutamine protein aggregation and toxicity in transgenic Caenorhabditis elegans models of Huntington's disease.

Huntington's disease (HD) is an autosomal dominant neurodegenerative disorder characterized by a repeat of the cytosine-adenine-guanine trinucleotide (CAG) in the huntingtin gene (HTT). This results in the translation of a mutant huntingtin (mHTT) protein with an abnormally long polyglutamine (polyQ) repeat. The pathology of HD leads to neuronal cell loss, motor abnormalities, and dementia.

Effect of adapted ice cream on nutritional status and oral mucositis in cancer patients undergoing chemotherapy: protocol study for a randomized controlled trial.

Background And Aims: Chemotherapy is one of the treatments of choice for patients with hematological or head and neck neoplasms. However, chemotherapy promotes elevate occurrence of adverse events and many of them directly impact nutritional status and patients' quality of life, which may include a low treatment tolerance. Suggested mechanisms include inflammation and oxidative stress as contributing factors to adverse effects of chemotherapy.

Body fat is related with poor motor skills and physical fitness in socially assisted children and adolescents regardless of age, sex, and body mass index.

Objective: To analyze the relationship between body fat, motor skills, and physical fitness in children and adolescents.

Methods: 216 children and adolescents (143 males and 73 females, aged 5-15 years) from a social project composed this study. Body mass and height were measured to calculate the body mass index (BMI).

New potential susceptibility factors contributing to tomato bacterial spot disease.

The label-free shotgun proteomics analysis carried out in this study aimed to understand the molecular mechanisms that contribute towards tomato susceptibility to Xanthomonas euvesicatoria pv. perforans (Xep). To achieve this, comparative proteomics was performed on susceptible inoculated plants with the bacterium and the control group (saline solution) at 24 and 48 h after inoculation (hai).

SURVEY OF Salmonella spp., Escherichia coli and Staphylococcus aureus IN ARDEIDS: INVESTIGATION OF POTENTIAL RESERVOIRS.

Ardeids are wild birds well adapted to urban and periurban environments. However, the association of wildlife with humans and livestock increases the chances of transmission of microorganisms between wild animals, domestic animals and humans. The present study aimed to investigate the occurrence of Salmonella spp.

Neuropsychiatric manifestations in systemic lupus erythematosus and Sjogren's disease.

Introduction: Autoimmune diseases often present in a systemic manner, affecting various organs and tissues. Involvement of the central and peripheral nervous system is not uncommon in these conditions and is associated with high morbidity and mortality. Therefore, early recognition of the neuropsychiatric manifestations associated with rheumatologic diseases is essential for the introduction of appropriate therapies with the objective of providing a better quality of life for individuals.

Pharmacogenetic Testing in Admixed Populations: Frequency of the AMR PGx Working Group Tier 1 Variant Alleles in Brazilians.

This article examines the frequency distribution of Tier 1 pharmacogenetic variants of the Association for Molecular Pathology Pharmacogenomics Working Group Recommendations in two large (>1.000 individuals) cohorts of the admixed Brazilian population, and in patients from the Brazilian Public Health System enrolled in pharmacogenetic trials. Three Tier 1 variants, all in DPYD, were consistently absent, which may justify their non-inclusion in genotyping panels for Brazilians; 13 variants had frequency < 1.

Six-month safety and efficacy outcomes from the randomized-controlled arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) trial.

Stenosis within the arteriovenous fistula (AVF) of hemodialysis patients leads to vascular access dysfunction and inadequate hemodialysis. Percutaneous transluminal angioplasty (PTA) is the standard therapy for stenosis. However, rates of restenosis and loss of access patency remain high.

Insights into the use of DNA content in head and neck squamous cell carcinoma as a method for patient stratification and targeted therapy: Revisiting old concepts and exploring new possibilities.

Background: This review aimed to emphasize the implications of DNA content in head and neck squamous cell carcinoma (HNSCC), focusing on its predictive value, role in patient stratification, and potential as a therapeutic target for this malignancy.

Methods: A narrative review of the literature was conducted through electronic database searches.

Results: In conventional HNSCC, aneuploid tumors are associated with increased lymph node metastasis, locoregional recurrences, poor response to radiotherapy and chemotherapy, and worse prognosis.

Current level, sources, and risk of human exposure to PAHs, PBDEs and PCBs in South American outdoor air: A critical review.

This study provides comprehensive overview of the current level, sources and human exposure risk to hazardous polycyclic aromatic hydrocarbons (PAHs), polybrominated diphenyl ethers (PBDEs), and polychlorinated biphenyls (PCBs) in South American outdoor air. Research documents were obtainable for only 6 countries within the target period (2014 - 2024). For all contaminants, urban concentrations exceeded that of rural/remote locations.