ENGLISH

Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective

By Maria Cristina Galli , Mercedes Serabian (eds.)

Book information

Publisher
Springer International Publishing
Year
2015
ISBN
978-3-319-18617-7, 978-3-319-18618-4
DOI
10.1007/978-3-319-18618-4
Language
english
Format
PDF
Filesize
5 MB (5104123 bytes)
Series
Advances in Experimental Medicine and Biology 871
Edition
1
Pages
XII, 230\235
Time added
2015-11-25 16:51:03
Gene Therapy

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.

Similar books

Session C11: Ancient Cultural Landscapes in South Europe – their Ecological Setting and Evolution, Session C22: Gardeners from South America, Session S04: Agro-Pastoralism and Early Metallurgy Sessions, Session WS29: The Idea of Enclosure in Recent Iberian Prehistory, Session C88: Rhytmes et causalites des dynamiques de l'anthropisation en Europe entre 6500 ET 500 BC: Hypotheses socio-culturelles et/ou climatiques: Proceedings of the XV UISPP World Congress (Lisbon 4-9 September 2006) / Actes du XV Congrès Mondial (Lisbonne 4-9 Septembre 2006) Vol.36

2010 · PDF

THE BRITISH ARMY IN INDIA: ITS PRESERVATION BY AN APPROPRIATE CLOTHING, HOUSING, LOCATING, RECREATIVE EMPLOYMENT, AND HOPEFUL ENCOURAGEMENT OF THE TROOPS. with AN APPENDIX ON INDIA : THE CLIMATE OP ITS HILLS ; THE DEVELOPMENT OF ITS RESODRCBS, INDUSTRY, AND ARTS ; THE ADMINISTRATION OF JUSTICE ; THE BLACK ACT ; THE PROGRESS OF CHRISTIANITY ; THE TRAFFIC IN OPIUM ; THE VALUE OF INDIA ; PERMANENT CAUSES OF DISAFFECTION, AND OF THE RECENT REBELLION ; THE TRADITIONARY POLICY; MISGOVERNMENT BY NATIVE RULERS ; ANNEXATIONS OF THEIR TERRITORY, ETC.

1858 · PDF