Publications by authors named "Sunju Ahn"
Standardization and quality assessment for human intestinal organoids.
Front Cell Dev Biol
September 2024
To enhance the practical application of intestinal organoids, it is imperative to establish standardized guidelines. This proposed standardization outlines a comprehensive framework to ensure consistency and reliability in the development, characterization, and application of intestinal organoids. The recommended guidelines encompass crucial parameters, including culture conditions, critical quality attributes, quality control measures, and functional assessments, aimed at fostering a standardized approach across diverse research initiatives.
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- Scientific research is moving towards alternative testing methods to replace animal testing, using cells, tissues, and artificial models.
- In western countries, a ban on animal testing for cosmetics has encouraged the use of artificial skin for toxicity tests.
- To ensure consistent results, standard guidelines for developing and using skin organoids are being established, covering factors like cell sourcing, culture methods, and quality assessment.
Article Synopsis
- - This study provides a detailed overview of brain organoids, including expert insights and technical information on their definitions, characteristics, and culture methods, aimed at improving their use in research.
- - Brain organoids are 3D human cell models that replicate the nervous system, offering significant advantages over traditional 2D methods by mimicking anatomical structures and complex neuronal networks.
- - The research highlights the potential of brain organoids for studying nervous system development and cell interactions, enabling researchers to model diseases more effectively and overcome limitations of conventional culture methods.
Cardiac organoids have emerged as invaluable tools for assessing the impact of diverse substances on heart function. This report introduces guidelines for general requirements for manufacturing cardiac organoids and conducting cardiac organoid-based assays, encompassing protocols, analytical methodologies, and ethical considerations. In the quest to employ recently developed three-dimensional cardiac organoid models as substitutes for animal testing, it becomes imperative to establish robust criteria for evaluating organoid quality and conducting toxicity assessments.
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- The guideline aims to establish basic standards for the creation, maintenance, and quality control of human lung organoids used in research for testing respiratory system health.
- It serves as a foundational resource for developing alternative testing methods that can be used in various contexts such as research, clinical, and commercial applications.
- Regulatory experts and researchers can also reference this guideline to evaluate the safety and efficacy of products related to lung health.
Article Synopsis
- Recent regulatory updates focus on using in vitro testing platforms for preclinical drug evaluations and toxicity assessments, highlighting the need for advanced tissue models that replicate liver functions.
- Liver organoids, grown from human cells, show potential as effective tools for drug testing, but their regulatory acceptance is challenged by the absence of standardized quality evaluation methods.
- The paper outlines proposed quality standards for liver organoids that cover aspects like cell source validation, organoid production, and functional testing to improve reliability and promote the use of organoids in drug development as alternatives to animal testing.
Article Synopsis
- Recent advancements in organoid technology are pushing for its use instead of animal testing in research.
- Organoids are particularly useful for testing the toxicity of drugs and chemicals.
- The paper aims to establish basic guidelines for using human kidney organoids from stem cells as a model for evaluating toxicity.
Article Synopsis
- * Despite its promise, there's significant variability in how organoids are produced across labs, leading to low reproducibility and a lack of standardized quality evaluation.
- * To address these issues, South Korea launched the Organoid Standards Initiative in September 2023, creating general guidelines for organoid manufacturing and evaluation to enhance consistency and regulatory acceptance.
Article Synopsis
- The paper outlines guidelines for managing the packaging, storage, transportation, and traceability of source cells crucial for organoid research, aiming to ensure their quality and integrity throughout the process.
- It emphasizes the importance of a cohesive strategy to prevent contamination and deterioration, which can compromise the safety and effectiveness of the source cells.
- The guidelines include quality control measures across the supply chain, recommending specific practices for packaging, transport, and storage, and stress the need for an integrated management system to enhance global sharing and utilization of source cells in research.
Network analysis for estimating standardization trends in genomics using MEDLINE.
BMC Med Res Methodol
October 2022
Article Synopsis
- Biotechnology in genomics has rapidly advanced in clinical settings, but a lack of applicable standards causes interoperability and reusability challenges across different technologies.
- An analysis of 16,538 articles from PubMed indicated a significant increase in research trends post-2003, particularly after major advancements like the completion of the human genome project and US-FDA approval of next-generation sequencers.
- The study highlights the need for standardization in clinical genetics, identifying key trends and areas for improvement based on comprehensive content and statistical analyses.
Development of clinical contents model markup language for electronic health records.
Healthc Inform Res
September 2012
Objectives: To develop dedicated markup language for clinical contents models (CCM) to facilitate the active use of CCM in electronic health record systems.
Methods: Based on analysis of the structure and characteristics of CCM in the clinical domain, we designed extensible markup language (XML) based CCM markup language (CCML) schema manually.
Results: CCML faithfully reflects CCM in both the syntactic and semantic aspects.
Article Synopsis
- The study aimed to create and validate quality metrics for detailed clinical models (DCMs) using the ISO/IEC 9126 software evaluation model.
- A two-round Delphi survey with 9 international experts was conducted to assess the metrics' face and content validity, resulting in 8 evaluation domains and 29 quality metrics.
- The metrics received a high reliability score (kappa of 0.73), indicating they are robust tools that can help DCM developers and clinical users make informed decisions.
A development of conceptual framework for structured data entry in procedure.
AMIA Annu Symp Proc
November 2008
This study was performed to provide the well-designed conceptual framework of clinical contents in procedures that enables clinicians to execute structured data entry at the point of care. The conceptual framework was developed through applying the ISO's conceptual framework for clinical contents modeling, semantic structuring, and using the Entity-Attribute-Value (EAV) model for data representation. We provided the conceptual framework in procedures, including twenty-one attributes and structured clinical data sets for operation records that are six diseases based on the conceptual framework.
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