<Literature List>
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Regulatory systems and requirements for clinical trials of AAV-based gene therapies – Perspectives from six Asian countries or regions: Report from the 6th Asia Partnership Conference of Regenerative Medicine – April 20, 2023 (Regenerative Therapy 26 (2024) 334-345)
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Comparison of guidelines for biological ancillary materials used for the manufacture of gene and cellular therapy products in Asia (Cytotherapy 2023 Feb;25(2):220-228)
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Non-clinical, quality and environmental impact assessments of cell and gene therapy products: Report on the 5th Asia Partnership Conference of Regenerative Medicine - April 7, 2022 (Cytotherapy 2023, 25(7) 683-698)
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Nonclinical and quality assessment of cell therapy products: Report on the 4th Asia Partnership Conference of Regenerative Medicine, April 15, 2021 (Cytotherapy 2022, 24 (9) 892-904)
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Nonclinical assessment of cell therapy products: the perspective from five Asian countries/regions based on regulatory guidelines and the underpinning rationales (Cytotherapy 2021, 21 1465-3249)
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Gaps between Asian regulations for eligibility of human mesenchymal stromal cells as starting materials of cell therapy products and comparability of mesenchymal stromal cell-based products subject to changes in their manufacturing process (Regenerative Therapy 15 (2020) 265-273)