| 書(shū)目名稱(chēng) | Regulatory Aspects of Gene Therapy and Cell Therapy Products | | 副標(biāo)題 | A Global Perspective | | 編輯 | Maria Cristina Galli,Mercedes Serabian | | 視頻video | http://file.papertrans.cn/826/825727/825727.mp4 | | 概述 | Discusses the basic background, regulatory policies, and requirements applied in different global regions for the development of gene therapy (GT) and cell therapy (CT) medicinal products.Offers the p | | 叢書(shū)名稱(chēng) | Advances in Experimental Medicine and Biology | | 圖書(shū)封面 |  | | 描述 | .This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. .Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective .is part of the .American Society of Gene and Cell Therapy .sub-series of the highly successful .Advances in Experimental Medicine and Biology .series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.. | | 出版日期 | Book 20151st edition | | 關(guān)鍵詞 | Cell therapy; Cell therapy products; Gene therapy; Regulatory oversight; Regulatory policies | | 版次 | 1 | | doi | https://doi.org/10.1007/978-3-319-18618-4 | | isbn_softcover | 978-3-319-35729-4 | | isbn_ebook | 978-3-319-18618-4Series ISSN 0065-2598 Series E-ISSN 2214-8019 | | issn_series | 0065-2598 | | copyright | American Society of Gene and Cell Therapy 2015 |
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