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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).</p>
<p>It addresses quality attributes relevant to intestinal organoid performance in endpoint assays. These include structural fidelity, functional relevance, basic genetic stability and reproducibility.</p>
<p>This document is applicable to hIOs used in drug screening, safety assessment, disease modeling and other non-clinical research applications.</p>
<p>Disease models generated from PSCs, engineered lines or non-pathological donor-derived materials are within the scope of this document, whereas tumour-derived organoids and organoids directly derived from pathological tissues are excluded.</p>
<p>This document does not apply to hIOs intended for in vivo human application, clinical 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).</p>
<p>It addresses quality attributes relevant to intestinal organoid performance in endpoint assays. These include structural fidelity, functional relevance, basic genetic stability and reproducibility.</p>
<p>This document is applicable to hIOs used in drug screening, safety assessment, disease modeling and other non-clinical research applications.</p>
<p>Disease models generated from PSCs, engineered lines or non-pathological donor-derived materials are within the scope of this document, whereas tumour-derived organoids and organoids directly derived from pathological tissues are excluded.</p>
<p>This document does not apply to hIOs intended for in vivo human application, clinical use, or therapeutic purposes.</p>
