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Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective (Advances in Experimental Medicine and Biology, 1430) by Maria Cristina Galli; Mercedes Serabian; American Society of Gene & Cell Therapy is a nonfiction available to read on EtoBox.
What is Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective (Advances in Experimental Medicine and Biology, 1430) about?
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 t
Who reads Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective (Advances in Experimental Medicine and Biology, 1430)?
It is typically read by self-directed learners exploring a subject in depth.
Common subject areas: history, science, philosophy, social sciences.
- Author
- Maria Cristina Galli; Mercedes Serabian; American Society of Gene & Cell Therapy
- Publisher
- Springer International Publishing AG
- Published
- 2023
- Language
- EN
- ISBN
- 9783319186177
- Category
- nonfiction
- Subjects
- Medical, Science, Biology
Other editions & translations
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