Informējam, ka Sistēma pielāgota darbam ar interneta pārlūkprogrammu Internet Explorer (8. un jaunākām versijām) un Mozilla Firefox (3.6 un jaunākām versijām).
Izmantojot citu interneta pārlūkprogrammu, brīdinām, ka Sistēmas funkcionalitāte var tikt traucēta.
<p>This document specifies the quality assessment criteria and methods for human intestinal organoids (hIOs), derived from pluripotent stem cells (PSCs) and tissue-derived stem cells (TSCs), to ensure their consistency and reliability in research and non-clinical <em>in vitro</em> applications. </p>
<p>It provides standardized guidelines for evaluating critical quality attributes (CQAs), including structural fidelity, functional relevance, genetic stability, and reproducibility.</p>
<p>This document aims to support the use of hIOs in drug screening, disease modeling, and non-clinical research applications by providing a comprehensive framework for assessing their quality and suitability for various life science purposes.</p>
<p>This document does not include tissue-derived organoids from pathological tissues (e.g., tumor-derived organoids) due to inherent variability.</p>
<p>This document does not apply to hIOs intended for <em>in vivo</em> human application, clinical use, diagnostic use, or therapeutic purposes, as these applications require additional regulatory considerations beyond the scope defined here.</p>
Reģistrācijas numurs (WIID)
91444
Darbības sfēra
<p>This document specifies the quality assessment criteria and methods for human intestinal organoids (hIOs), derived from pluripotent stem cells (PSCs) and tissue-derived stem cells (TSCs), to ensure their consistency and reliability in research and non-clinical <em>in vitro</em> applications. </p>
<p>It provides standardized guidelines for evaluating critical quality attributes (CQAs), including structural fidelity, functional relevance, genetic stability, and reproducibility.</p>
<p>This document aims to support the use of hIOs in drug screening, disease modeling, and non-clinical research applications by providing a comprehensive framework for assessing their quality and suitability for various life science purposes.</p>
<p>This document does not include tissue-derived organoids from pathological tissues (e.g., tumor-derived organoids) due to inherent variability.</p>
<p>This document does not apply to hIOs intended for <em>in vivo</em> human application, clinical use, diagnostic use, or therapeutic purposes, as these applications require additional regulatory considerations beyond the scope defined here.</p>
