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New Drug Application of Biotechnology products in Japan
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Guide: Investigational medicinal product dossier for ATMP
Web15 sep. 2024 · We found total CD11b + F4/80 + macrophages were significantly higher in CtD and CtD CT135-infected mice compared to mock infection but did not differ between the two groups of infected mice. We next investigated if macrophages between groups differed in M1 (MHCII, iNOS, and TNF-α) and M2 (CD206, Arginase, and IL-10) … WebThe eCTD format is regarded as the principal electronic submission format in EU for human medicinal products and is the only electronic format that is accepted by the EMA (except … WebFor acceptable file formats, please refer to the electronic Common Technical Document (eCTD) and non-eCTD guidance documents. Mock-ups of electronic labels consist only of those parts of the platform that speak directly to topics covered by … nvme-of offload