Regulatory Aspects of Gene Therapy and Cell Therapy Products (eBook, PDF)
eBook, PDF

Regulatory Aspects of Gene Therapy and Cell Therapy Products (eBook, PDF)

A Global Perspective

Redaktion: Galli, Maria Cristina; Serabian, Mercedes
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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...

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