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Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective (Advances in Experimental Medicine and Biology) | Paperback

by Maria Cristina Galli (Editor), Mercedes Serabian (Editor)


List Price: $159.99  
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Binding:  Paperback
Publisher:  Springer
Edition:  Softcover reprint of the original 1st ed. 2015th Edition
Page Count:  230 Pages
Publication Date:  October 22, 2016
Sales Rank:  2375033rd



EDITORIAL REVIEWS


Product Description
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.

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