{"product_id":"guide-to-cell-therapy-gxp-quality-standards-in-the-development-of-cell-based-medicines-in-non-pharmaceutical-environments-paperback-9780128031155","title":"Guide to Cell Therapy GxP; Quality Standards in the Development of Cell-Based Medicines in Non-pharmaceutical Environments (Paperback) 9780128031155","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eGuide to Cell Therapy GxP\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003eQuality Standards in the Development of Cell-Based Medicines in Non-pharmaceutical Environments\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cem\u003eThis book provides the quality standards used in the development of stem cell-based medicines in non-pharmaceutical environments, and includes all information that should be used in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation.\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eJoaquim Vives (Author), Gloria Carmona (Author)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780128031155, Elsevier Science\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003ePaperback, published 30 July 2015\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e266 pages\u003cbr\u003e22.9 x 15.1 x 1.8 cm, 0.45 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003cp\u003e\u003ci\u003eGuide to Cell Therapy GxP\u003c\/i\u003e is a practical guide to the implementation of quality assurance systems for the successful performance of all cell-based clinical trials. The book covers all information that needs to be included in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond.  \u003ci\u003eGuide to Cell Therapy GxP\u003c\/i\u003e bridges a knowledge gap with the inclusion of examples of design of GLP-compliant preclinical studies; design of bioprocesses for autologous\/allogeneic therapies; and instruction on how to implement GLP\/GMP standards in centers accredited with other quality assurance standards. \u003ci\u003eGuide to Cell Therapy GxP\u003c\/i\u003e is an essential resource for scientists and researchers in hospitals, transfusion centers, tissue banks, and other research institutes who may not be familiar with the good scientific practice regulations that were originally designed for product development in corporate environments. This book is also a thorough resource for PhD students, Post-docs, Principal Investigators, Quality Assurance Units, and Government Inspectors who want to learn more about how quality standards are implemented in public institutions developing cell-based products.\u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eForewordPreface1. Overview of the development programme of a cell-based medicine 2. European regulatory framework for the development of cell-based medicines3. Non-clinical studies for cell-based medicines4. GMP compliance in the manufacture of cell-based medicines5. GCP compliance in non-profit institutions6. Compatibility of GxP with existing quality standards\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Cellular biology [\u003ca title=\"See our other books on Cellular biology\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Cellular%20biology%20%5Bcytology%5D%20%5BPSF%5D%22\"\u003ecytology PSF\u003c\/a\u003e], Biomedical engineering [\u003ca title=\"See our other books on Biomedical engineering\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Biomedical%20engineering%20%5BMQW%5D%22\"\u003eMQW\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Academic Press","offers":[{"title":"Default Title","offer_id":46649599394072,"sku":"9780128031155","price":77.19,"currency_code":"GBP","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/products\/9780128031155.jpg?v=1694102099","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/guide-to-cell-therapy-gxp-quality-standards-in-the-development-of-cell-based-medicines-in-non-pharmaceutical-environments-paperback-9780128031155","provider":"Freshly Printed Books","version":"1.0","type":"link"}