Publications by authors named "Azadeh M"

Piezoelectric ceramics tailored for high-power resonance applications are investigated, utilizing a composite structure comprising the ferroelectric phase (K,Na)NbO as a matrix integrated with the alkali titanoniobate dielectric phase KTiNbO. Achieving a mechanical quality factor of 750, comparable to lead-based counterparts, highlights their suitability for demanding applications. Crucially, these ceramics exhibit exceptional temperature stability of electromechanical properties, a critical attribute for real-world applications subject to temperature variations.

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Background: Multiple sclerosis (MS) is one of the three leading neurodegenerative diseases worldwide. Gene expression profile studies play an important role in recognizing and preventing disease. Considering the inherent ability of biomarkers to diagnose and prognose the occurrence of a disease, with the aim of gene therapy and changing gene expression, it can be helped to treat it.

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Aberrant or dysfunctional cellular enzymes are responsible for a wide range of diseases including cancer, neurodegenerative conditions, and metabolic disorders. Deficiencies in enzyme level or biofunction may lead to intracellular accumulation of substrate to toxic levels and interfere with overall cellular function, ultimately leading to cell damage, disease, and death. Marketed therapeutic interventions for inherited monogenic enzyme deficiency disorders include enzyme replacement therapy and small molecule chaperones.

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Article Synopsis
  • Immunogenicity testing helps understand the immune response to protein therapies, and neutralizing antibody (NAb) assays are key to characterizing anti-drug antibody responses.
  • A group of NAb assay experts has created standardized reporting recommendations to streamline communication and facilitate regulatory submissions.
  • The document outlines essential components for NAb sample analysis reports, though it does not cover the interpretation of immunogenicity data related to safety and efficacy.
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Article Synopsis
  • The 17th Workshop on Recent Issues in Bioanalysis (17 WRIB) occurred in Orlando from June 19-23, 2023, gathering over 1000 professionals from pharma, biotech, and regulatory agencies to discuss current bioanalysis topics.
  • The event featured 3 Main Workshops and 7 Specialized Workshops covering key issues like biomarkers, immunogenicity, and evolving regulations including the EU IVDR and US FDA remote assessments.
  • The outcomes of the workshop led to a comprehensive White Paper offering recommendations for improving bioanalytical practices and regulatory compliance, divided into three parts focusing on different aspects of bioanalysis.
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The 17 Workshop on Recent Issues in Bioanalysis (17 WRIB) took place in Orlando, FL, USA on 19-23 June 2023. 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 17 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.

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The emerging use of qPCR and dPCR in regulated bioanalysis and absence of regulatory guidance on assay validations for these platforms has resulted in discussions on lack of harmonization on assay design and appropriate acceptance criteria for these assays. Both qPCR and dPCR are extensively used to answer bioanalytical questions for novel modalities such as cell and gene therapies. Following cross-industry conversations on the lack of information and guidelines for these assays, an American Association of Pharmaceutical Scientists working group was formed to address these gaps by bringing together 37 industry experts from 24 organizations to discuss best practices to gain a better understanding in the industry and facilitate filings to health authorities.

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Background: Gastric cancer (GC) is the second most frequent cause of cancer-related death worldwide and the fourth most common malignancy. Despite significant improvements in patient survival over the past few decades, the prognosis for patients with GC remains dismal because of the high recurrence rate. In this comprehensive system biology and experimental investigation, we aimed to find new novel diagnostic biomarkers of GC through a regulatory RNA interaction network.

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Aims: Blood biomarkers can improve drug development for Alzheimer's disease (AD) and its treatment. Neuron-derived extracellular vesicles (NDEVs) in plasma offer a minimally invasive platform for developing novel biomarkers that may be used to monitor the diverse pathogenic processes involved in AD. However, NDEVs comprise only a minor fraction of circulating extracellular vesicles (EVs).

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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.

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Dental resin composites are widely used as restorative materials due to their natural aesthetic and versatile properties. However, there has been limited research on the degradation mechanisms of these composites in gastric acid environments, which would be common in patients with gastroesophageal reflux. This study aims to investigate the degradation behavior of dental composites immersed in simulated oral environments, including acid, saliva, and water.

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Background: According to the bioinformatics analyses and previous studies, bone morphogenetic protein receptor type 1B () dysregulation could remarkably affect breast cancer (BC) status as a potential biomarker and tumor suppressor. Therefore, the analysis of the expression level of and other relevant biological factors such as microRNAs, long non-coding RNAs, downstream proteins in the relevant signaling pathways, and finding the accurate biological mechanism of could be helpful for a better understanding of BC pathogenicity and discovering the new treatment methods and drugs.

Materials And Methods: R Studio software (4.

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Colorectal cancer (CRC) is the third most prevalent cancer with the second-highest mortality rate worldwide. microRNAs (miRNAs) of cancer-derived exosomes have shown promising diagnosis potential. Recent studies have shown the metastatic potential of a specific group of microRNAs called metastasis.

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The number of approved or investigational late phase viral vector gene therapies (GTx) has been rapidly growing. The adeno-associated virus vector (AAV) technology continues to be the most used GTx platform of choice. The presence of pre-existing anti-AAV immunity has been firmly established and is broadly viewed as a potential deterrent for successful AAV transduction with a possibility of negative impact on clinical efficacy and a connection to adverse events.

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Recent advances in perovskite ferroelectrics have fostered a host of exciting sensors and actuators. Defect engineering provides critical control of the performance of ferroelectric materials, especially lead-free ones. However, it remains a challenge to quantitatively study the concentration of defects due to the complexity of measurement techniques.

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A clear scientific and operational need exists for harmonized bioanalytical immunogenicity study reporting to facilitate communication of immunogenicity findings and expedient review by industry and health authorities. To address these key bioanalytical reporting gaps and provide a report structure for documenting immunogenicity results, this cross-industry group was formed to establish harmonized recommendations and a develop a submission template to facilitate agency filings. Provided here are recommendations for reporting clinical anti-drug antibody (ADA) assay results using ligand-binding assay technologies.

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Breast cancer (BC) is one of the leading cancers in the world, which has become an increasing serious problem. In this context, reports demonstrate that some long noncoding RNAs (lncRNAs) play significant regulatory roles in breast tumorigenesis and BC progression via various pathways and act as endogenous RNAs. Finding their dysregulation in cancer and evaluating their interaction with other molecules, such as short noncoding RNAs "microRNA (miRNAs)" as well as various genes, are the most important parts in cancer diagnostics.

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Background: The most frequent malignancy in women is breast cancer (BC). Gastric cancer (GC) is also the leading cause of cancer-related mortality. Long non-coding RNAs (lncRNAs) are thought to be important neurotic regulators in malignant tumors.

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The number of viral vector-based gene therapies (GTx) continues to grow with two products (Zolgensma® and Luxturna®) approved in the USA as of March 2021. To date, the most commonly used vectors are adeno-associated virus-based (AAV). The pre-existing humoral immunity against AAV (anti-AAV antibodies) has been well described and is expected as a consequence of prior AAV exposure.

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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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A higher expression of MALAT1 has been reported in breast cancer. However, more studies are needed to decipher the mechanisms by which this lncRNA imposes its oncogenic effects. In this study, blood and tissue samples were taken from healthy normal and breast cancer subjects.

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Background: Gastric cancer is the fifth most common cancer worldwide. Along with environmental factors, such as Helicobacter pylori (H. pylori) infection, genetic changes play important roles in gastric tumor formations.

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Thermal discomfort is one of the main triggers for occupants' interactions with components of the built environment such as adjustments of thermostats and/or opening windows and strongly related to the energy use in buildings. Understanding causes for thermal (dis-)comfort is crucial for design and operation of any type of building. The assessment of human thermal perception through rating scales, for example in post-occupancy studies, has been applied for several decades; however, long-existing assumptions related to these rating scales had been questioned by several researchers.

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