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<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).<span lang="EN-US"> It addresses quality attributes relevant to intestinal organoid performance in endpoint assays. These include structural fidelity, functional relevance, basic genetic stability and reproducibility.</span></p>
<p><span lang="EN-US">This document is applicable to hIOs used in drug screening, safety assessment, disease modelling and other non-clinical research applications. </span></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><span lang="EN-US">This document does not include tumour-derived organoids or organoids directly derived from pathological tissues. </span></p>
<p>This document does not apply to hIOs intended for <em>in vivo</em> human application, clinical use, diagnostic use, or therapeutic purposes.</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).<span lang="EN-US"> It addresses quality attributes relevant to intestinal organoid performance in endpoint assays. These include structural fidelity, functional relevance, basic genetic stability and reproducibility.</span></p>
<p><span lang="EN-US">This document is applicable to hIOs used in drug screening, safety assessment, disease modelling and other non-clinical research applications. </span></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><span lang="EN-US">This document does not include tumour-derived organoids or organoids directly derived from pathological tissues. </span></p>
<p>This document does not apply to hIOs intended for <em>in vivo</em> human application, clinical use, diagnostic use, or therapeutic purposes.</p>
