现货 Guide to Cell Therapy Gxp: Quality Standards in the Development of Cell-Based Medicines in Non-Pharmaceutical Environments[9780128031155]

1053 九五品

库存2件

上海宝山

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作者Vives, Joaquim ; Carmona, Gloria

出版社Academic Press

ISBN9780128031155

出版时间2015-07

装帧平装

纸张其他

页数266页

正文语种英语

上书时间2023-04-11

已实名已认证进店收藏店铺

商品描述: Guide to Cell Therapy GxP: Quality Standards in the Development of Cell-Based Medicines in Non-Pharmaceutical Environments provides a practical guide to the implementation of quality assurance systems for successful performance of all cell-based clinical trials. The book includes all information that should be used in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond, bridging the gap in knowledge with the inclusion of examples of design of GLP-compliant preclinical studies, design of bioprocesses for autologous/allogeneic therapies, risk-based assessment of GMP-compliant processes for the production of cell-based therapies, and instructions on how to implement GLP/GMP standards in centers accredited with other quality assurance standards (JACIE; FACT/NETCORD, ISO9001, and others).* Provides easy access to important information on current regulations, state-of-the-art techniques, and recent advances otherwise scattered on various funding websites, within conference proceedings, or maintained in local knowledge* Features protocols, techniques for trouble-shooting common problems, and an explanation of the advantages and limitations of a technique in generating conclusive data* Includes practical examples of successful implementation of quality standards