Regulatory aspects of gene therapy and cell therapy products: a global perspective
Gespeichert in:
| Weitere Verfasser: | , |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Cham ; Heidelberg ; New York ; Dordrecht ; London
Springer
[2015]
|
| Schriftenreihe: | Advances in experimental medicine and biology
volume 871 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis Klappentext |
| Beschreibung: | xii, 230 Seiten Diagramme |
| ISBN: | 9783319186177 9783319357294 |
Internformat
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Datensatz im Suchindex
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| adam_text | Contents United States Food and Drug Administration Regulation of Gene and Cell Therapies............................................................................... Alexander M. Bailey, Judith Arcidiacono, Kimberly A. Benton, Zenobia Taraporewala, and Steve Winitsky The National Institutes of Health Oversight of Human Gene Transfer Research: Enhancing Science and Safety........ .............................. Marina O’Reilly, Robert Jambou, Eugene Rosenthal, Maureen Montgomery, Morad Hassani, Linda Gargiulo, and Jacqueline Corrigan-Curay Regulatory Oversight of Cell and Gene Therapy Products in Canada............................................................................................. Anthony Ridgway, Francisca Agbanyo, Jian Wang, and Michael Rosu-Myles Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products................................................................................ Sophie Lucas-Samuel, Nicolas Ferry, and Jean-Hugues Trouvin Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.......................................................................................... Matthias Renner, Brigitte Anliker, Ralf Sanzenbacher, and Silke Schuele Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective........................ Paula Salmikangas, Martina Schuessler-Lenz, Sol Ruiz, Patrick Celis, Ilona Reischl, Margarida Menezes-Ferreira, Egbert Flory, Matthias Renner,
and Nicolas Ferry Requirements for Clinical Trials with Gene Therapy and Transplant Products in Switzerland...................................................................................... Andreas Marti 1 31 49 73 87 103 131 vii
viii Contents Regulatory Frameworks for Gene and Cell Therapies in Japan................ Daisuke Maeda, Terahide Yamaguchi, Takarni Ishizuka, Masakazu Hirata, Kazuhiro Takekita, and Daisaku Sato Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea............................................................................................... Minjoung Choi, Euiri Han, Sunmi Lee, Taegyun Kim, and Won Shin Regulation of Cell and Gene Therapy Medicinal Products in Taiwan............................................................................................................... Yi-Chu Lin, Po-Yu Wang, Shih-Chih Tsai, Chien-Liang Lin, Hsuen-Yung Tai, Chi-Fang Lo, Shiow-Ing Wu, Yu-Mei Chiang, and Li-Ling Liu Regulatory Oversight of Cell- and Tissue-Based Therapeutic Products and Gene Therapy Products in Singapore.................................... Choon Wee Goh, Srinivasan N. Kellathur, Lee Lee Ong, and Xiaofeng Wu 147 163 181 195 The Regulatory Pathway for Advanced Cell Therapy and Gene Therapy Products in Brazil: A Road to Be Built...................... . Daniel Roberto Coradi de Freitas 213 Index 221
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.
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| illustrated | Not Illustrated |
| indexdate | 2024-07-10T07:41:29Z |
| institution | BVB |
| isbn | 9783319186177 9783319357294 |
| language | English |
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| series | Advances in experimental medicine and biology |
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| spelling | Regulatory aspects of gene therapy and cell therapy products a global perspective Maria Cristina Galli, Mercedes Serabian, editors Cham ; Heidelberg ; New York ; Dordrecht ; London Springer [2015] © 2015 xii, 230 Seiten Diagramme txt rdacontent n rdamedia nc rdacarrier Advances in experimental medicine and biology volume 871 Medicine Gene therapy Biomedicine Gene Therapy Medizin (DE-588)4143413-4 Aufsatzsammlung gnd-content Galli, Maria Cristina 1966- (DE-588)123447143 edt Serabian, Mercedes edt Erscheint auch als Online-Ausgabe, eBook 978-3-319-18618-4 Advances in experimental medicine and biology volume 871 (DE-604)BV000003102 871 Digitalisierung UB Passau - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029431797&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis Digitalisierung UB Passau - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029431797&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Klappentext |
| spellingShingle | Regulatory aspects of gene therapy and cell therapy products a global perspective Advances in experimental medicine and biology Medicine Gene therapy Biomedicine Gene Therapy Medizin |
| subject_GND | (DE-588)4143413-4 |
| title | Regulatory aspects of gene therapy and cell therapy products a global perspective |
| title_auth | Regulatory aspects of gene therapy and cell therapy products a global perspective |
| title_exact_search | Regulatory aspects of gene therapy and cell therapy products a global perspective |
| title_full | Regulatory aspects of gene therapy and cell therapy products a global perspective Maria Cristina Galli, Mercedes Serabian, editors |
| title_fullStr | Regulatory aspects of gene therapy and cell therapy products a global perspective Maria Cristina Galli, Mercedes Serabian, editors |
| title_full_unstemmed | Regulatory aspects of gene therapy and cell therapy products a global perspective Maria Cristina Galli, Mercedes Serabian, editors |
| title_short | Regulatory aspects of gene therapy and cell therapy products |
| title_sort | regulatory aspects of gene therapy and cell therapy products a global perspective |
| title_sub | a global perspective |
| topic | Medicine Gene therapy Biomedicine Gene Therapy Medizin |
| topic_facet | Medicine Gene therapy Biomedicine Gene Therapy Medizin Aufsatzsammlung |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029431797&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029431797&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV000003102 |
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