000			03902nam a2200433 i 4500
999			_c127403 _d127403
001			127403
003			ES-MaUEC
005			20230102114244.0
006			a||||fo|||| 00| 0
007			cr nn nnnaamaa
008			200205s2020 gw | s |||| 0|eng d
020			_a9783030356262
024	7		_a10.1007/978-3-030-35626-2 _2doi
040			_aES-MaUEC _bspa _cES-MaUEC _dES-MaUEC
050		4	_aR856 _b2020 EB
245	0	0	_aBiomedical Product Development: Bench to Bedside _cedited by Babak Arjmand, Moloud Payab, Parisa Goodarz
250			_aFirst edition 2020
264		1	_aCham _bSpringer International Publishing _c2020
300			_a1 recurso en línea (XIV, 157 páginas) _b16 ilustraciones a color
336			_2rdacontent _aTexto _btxt
337			_2rdamedia _aelectrónico _bc
338			_2rdacarrier _arecurso electrónico _bcr
490	0		_aLearning Materials in Biosciences _x2509-6125
490	0		_aBiomedical and Life Sciences (SpringerNature-11642)
490	0		_aBiomedical and Life Sciences (SpringerNature-43708)
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	3		_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.
988			_aSpringer_BiomedLife_13102020
650		7	_2embne _9143820 _aIngeniería biomédica
700	1		_aArjmand, Babak _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt
700	1		_aPayab, Moloud _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt
700	1		_aGoodarzi, Parisa _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt
710	2		_aSpringerLink
776	0	8	_iPrinted edition: _z9783030356255
776	0	8	_iPrinted edition: _z9783030356279
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-030-35626-2 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
942			_2lcc _cLE
998			_b11/2020 _dz _ek _zSI