Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective: 1430 (Advances in Experimental Medicine and Biology, 1430) - Image 1

£84.68

Springer Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective: 1430 (Advances in Experimental Medicine and Biology, 1430)

Name: Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective: 1430 (Advances in Experimental Medicine and Biology, 1430)
Brand: Springer
Price: 84.68 GBP
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Biological Science

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Description

This book discusses the different regulatory pathways for Advanced Therapy Medicinal Products implemented by national agencies in North and South America, Europe and Asia and by international bodies in the effort of international harmonization. This book represents an update of the first edition, as it covers regulatory novelties and accumulated experience in the regions already addressed. In addition, this new edition offers a wider international perspective: new chapters are included covering Advanced Therapy Medicinal Products regulations in India, Malaysia, Spain and Thailand, the European Pharmacopoeia texts for gene therapy medicinal products as well as international harmonization programs. 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 and therapeutic use of these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of Advanced Therapy Medicinal Products in the areas of product quality, pharmacology and toxicology, clinical trial design and HTA pathways, 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 & 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.

Product Specifications

Brand: Springer
Format: paperback
ASIN: 303134569X
Category: Books > Subjects > Science, Nature & Maths > Biological Sciences > Biological Science
Domain: Amazon UK
Release Date: 20 August 2024
Listed Since: 21 August 2024

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Springer Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective: 1430 (Advances in Experimental Medicine and Biology, 1430)

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