Galli Regulatory Aspects of Gene Therapy and Cell Therapy Products 9783031345661

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Автор: Galli
Название: Regulatory Aspects of Gene Therapy and Cell Therapy Products
Перевод названия: Нормативно-правовые аспекты генной терапии и продуктов клеточной терапии
ISBN: 9783031345661
Издательство: Springer
Классификация:

Медицинская генетика

Лечение и лечебно-профилактические средства

Клеточная биология (цитология)

ISBN-10: 3031345665
Обложка/Формат: Hardback
Страницы: 242
Вес: 0.00 кг.
Дата издания: 16.08.2023
Серия: Advances in experimental medicine and biology
Язык: English
Издание: 2nd ed. 2023
Иллюстрации: 36 illustrations, color; 1 illustrations, black and white; ix, 242 p. 37 illus., 36 illus. in color.
Размер: 254 x 178
Основная тема: Life Sciences
Подзаголовок: A global perspective
Ссылка на Издательство: Link
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Поставляется из: Германии
Описание: 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.
Дополнительное описание: Introduction (MCG and FN).- Updates on ATMP regulations from EU: experience with PRIME procedure and list of approved ATMP.- EU portal for clinical trials application.- European Pharmacopoeia texts on gene therapy medicinal products.- Updates on ATMP regu

Regulatory Aspects of Gene Therapy and Cell Therapy Products, Galli