Regulatory Aspects of Gene Therapy and Cell Therapy Products

A Global Perspective

Nonfiction, Health & Well Being, Medical, Medical Science, Genetics
Cover of the book Regulatory Aspects of Gene Therapy and Cell Therapy Products by , Springer International Publishing
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: ISBN: 9783319186184
Publisher: Springer International Publishing Publication: September 15, 2015
Imprint: Springer Language: English
Author:
ISBN: 9783319186184
Publisher: Springer International Publishing
Publication: September 15, 2015
Imprint: Springer
Language: English

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.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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.

More books from Springer International Publishing

Cover of the book Cruel Children in Popular Texts and Cultures by
Cover of the book Networked Systems by
Cover of the book Reviews of Environmental Contamination and Toxicology volume by
Cover of the book Spatio-temporal Intertwining by
Cover of the book Kaizen Planning, Implementing and Controlling by
Cover of the book Azokh Cave and the Transcaucasian Corridor by
Cover of the book The European Stability Mechanism before the Court of Justice of the European Union by
Cover of the book Mathematical Problem Solving by
Cover of the book Nonlinear Photonics in Mid-infrared Quantum Cascade Lasers by
Cover of the book Global Innovation of Teaching and Learning in Higher Education by
Cover of the book Resisting Carceral Violence by
Cover of the book Short Views on Insect Genomics and Proteomics by
Cover of the book Logarithmic Voltage-to-Time Converter for Analog-to-Digital Signal Conversion by
Cover of the book Connecting Women by
Cover of the book Security and Safety Interplay of Intelligent Software Systems by
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy