Standards and Regulatory Frameworks (for Cell- and Tissue-Based Products)

Maryam Arabi,Fereshteh Mohamadi-Jahani,Sepideh Alavi-Moghadam,Mina Abedi

Biomedical Product Development: Bench to BedsideLearning Materials in Biosciences（2020）

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摘要

Cell therapy, as a field of biotherapeutic medicines, concerns with global public health promotion. The complexity of human cell- and tissue-based products (HCTPs) in their structure, content, mode of action, and delivery confronts health relevant professionals, regulatory authorities, and manufacturers with some challenges from product design to delivery [1].

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关键词

regulatory frameworks,standards,products,tissue-based

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