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008			200205s2020 gw | o |||| 0|eng d
020			_a3030356264
024	7		_a10.1007/978-3-030-35626-2 _2doi
040			_bspa _dES-VaUE
050			_aRM301.25 _b.B56 2020 EB
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072		7	_aMED003040 _2bisacsh
072		7	_aMQW _2thema
082	0	4	_a610.28 _223
245	1	0	_aBiomedical Product Development: Bench to Bedside _cedited by Babak Arjmand, Moloud Payab, Parisa Goodarzi
250			_a1st ed. 2020
264		1	_aCham _bSpringer International Publishing _bImprint: Springer _c2020
300			_a1 online resource (XIV, 157 p. 16 illus. in color.)
336			_atext _btxt [ _2rdacontent]
337			_acomputer _bc [ _2rdamedia]
338			_aonline resource _bcr [ _2rdacarrier]
490	1		_aLearning Materials in Biosciences _x2509-6125
505	0		_a1. An Introduction to Biomedical Product Development -- 2. Basic Essentials and Applications of Quality Management System (QMS) in Biomedical Sciences -- 3. Principles of Good Laboratory Practice (GLP) -- 4. Design of Experimental Studies in Biomedical Sciences -- 5. Preclinical Studies for Development of Biomedical Products -- 6. Principles of Good Manufacturing Practice (GMP) -- 7.The importance of Cleanroom facility in manufacturing of biomedical products -- 8. Safety concerns and requirement of cell based products for clinical application -- 9. Standards and regulatory frameworks (for cell and tissue based products) -- 10. Principles of Good clinical Practice (GCP) -- 11. Design, performance and monitoring of clinical trials -- 12. Good Clinical Practice: Guidelines and Requirement -- 13. Ethical Considerations of Biomedical Products Development
520			_aThis textbook covers all the steps in manufacturing a biomedical product from bench to bedside. It specifically focuses on quality assurance and management and explains the different good practice principles in the various phases of product development as well as how to fulfill them: Good laboratory practice, good manufacturing practice and good clinical practice. It provides readers with the know-how to design biomedical experiments to ensure quality and integrity, to plan and conduct standard preclinical studies and to assure the quality of the final manufactured biomedical products. Importantly, it also addresses ethical concerns and considerations. The book discusses the guidelines and ethical considerations for preclinical and clinical studies, to allow readers to identify safety concerns regarding biomedical products and to improve pre-clinical studies for the development of better products. This textbook is a valuable guide for biomedical students (B.Sc., M.S., and Ph.D. students) in the field of molecular medicine, medical biotechnology, stem cell research and related areas, as well as for professionals such as quality control staff, tissue bankers, policy-makers and health professionals
650		0	_aBiomedical engineering
650		0	_aRegenerative medicine
650		0	_aTissue engineering
650		0	_aMedicine
650		0	_aPharmaceutical technology
650		0	_aBiotechnology
650	1	4	_aBiomedical Engineering/Biotechnology.
650	2	4	_aRegenerative Medicine/Tissue Engineering.
650	2	4	_aMedicine/Public Health, general.
650	2	4	_aBiomedical Engineering and Bioengineering.
650	2	4	_aPharmaceutical Sciences/Technology.
650	2	4	_aBiotechnology.
700	1		_aArjmand, Babak., _eeditor. _4edt. _4http://id.loc.gov/vocabulary/relators/edt
700	1		_aPayab, Moloud., _eeditor. _4edt. _4http://id.loc.gov/vocabulary/relators/edt
700	1		_aGoodarzi, Parisa., _eeditor. _4edt. _4http://id.loc.gov/vocabulary/relators/edt
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=http://link.springer.com/book/10.1007/978-3-030-35626-2 _zAcceso a este recurso digital (usuarios Universidad Europea de Valencia)
942			_2lcc _cLE
998			_db