Publications by authors named "Marcela Araya"

Article Synopsis
  • The 14th Workshop on Recent Issues in Bioanalysis (14 WRIB) took place virtually from June 15-29, 2020, attracting over 1000 participants from various sectors in the pharmaceutical and biotech industries, as well as regulatory agencies globally.
  • The event featured three main workshops and seven specialized workshops over 11 days, focusing on critical topics such as bioanalysis, biomarkers, immunogenicity, gene therapy, and vaccine development.
  • The associated 2020 White Paper offers recommendations based on discussions from the workshop and is divided into three parts, covering various aspects of bioanalytical practices and regulatory compliance, with some sections published in previous volumes of the journal Bioanalysis.
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Background: Some nutritional interventions have shown their efficacy in reducing gestational weight gain (GWG); however, their applicability in routine care is limited.

Objective: We assessed the effectiveness of a low-intensity and high-coverage nutritional intervention on maternal and offspring outcomes; the intervention enhanced existing nutritional health care standards and practices at the primary health care level in Chile.

Methods: This study was a cluster-randomized controlled trial of 12 primary health care centers (PHCCs) from Santiago, Chile.

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PEGylated biotherapeutics can elicit anti-PEG (polyethylene glycol) immune responses in patients treated with this category of drugs. While anti-PEG antibody assays for this class of biotherapeutics have become a common element of the clinical immunogenicity testing strategy, the overall antibody incidence induced by the nanoparticle (NP) delivery system (such as ACCURINS®) has not been fully studied to date. To support the immunogenicity assessment of one of Pfizer's NP-based therapeutics, consisting of gedatolisib (GEDA) encapsulated in ACCURINS® (GEDA-NP), we developed an anti-GEDA-NP antibody (ADA) assay on the MSD platform for the detection of GEDA-NP induced ADA in human serum.

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Assays for the detection and confirmation of anti-drug antibodies (ADA) are commonly used tools for assessing the immunogenicity of drug candidates in both clinical and nonclinical studies. During the development of such assays, it is typical to optimize the assay conditions based on factors such as sensitivity or signal/noise ratio (S/N) and is commonly done using an assay positive control (PC). However, even carefully optimized methods often suffer with problems due to low cut-point factors and failure to distinguish assay "noise" from a true biological response.

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Background: Lifestyle interventions are the primary prevention strategy for gestational diabetes (GDM) in obese/overweight women; however, these interventions have shown limited effectiveness. Omega-3 polyunsaturated fatty acids (PUFAs) intake has shown beneficial effects on glucose metabolism, lipid fractions and inflammatory factors in women who already have GDM. Combining PUFAs supplementation with a lifestyle intervention could achieve lower increase of glucose levels by improving insulin sensitivity.

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We report on a girl diagnosed prenatally with agenesis of the corpus callosum (ACC) on fetal ultrasound and MRI. On postnatal follow-up she was noted to have developmental delay, facial dysmorphism, autism spectrum disorder, and posterior polymorphous corneal dystrophy (PPD). Array-comparative genomic hybridization analysis (Array-CGH) showed a 2.

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Objectives: One of every four pregnant women in Chile is obese. Gestational obesity is associated with maternal metabolic complications in pregnancy (e.g.

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Background: Maternal obesity before and during pregnancy predicts maternal and infant risks of obesity and its associated metabolic conditions. Dietary and physical activity recommendations during pregnancy as well as weight monitoring are currently available in the Chilean primary health care system. However some of these recommendations are not updated and most of them are poorly implemented.

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Cyclic strabismus is a rare condition that usually occurs in children and is characterized by alternating intervals of straight and strabismic eyes. In adults with the condition, strabismus surgery often eliminates the cycles. We report a case of adult-onset cyclic esotropia that was converted into a cyclic exotropia.

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Accurate measurement of in vitro cell growth is critical for oncology drug development, but cell counting and the most accurate indirect proliferation assays are impractical. Here, we describe a robust alternative method that monitors proliferating cell thymidine kinase 1 (TK1) activity via LC-MS/MS quantification of 3'-deoxy-3'-fluorothymidine (FLT) and its monophosphate metabolite FLT-MP. LNCaP prostate cancer cells were cultured at four densities (20,000; 10,000; 5000; and 500 cells/well) and incubated with 2000 ng/mL FLT in multi-well plates.

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