國立高雄大學圖資館 |

語系: 繁體中文

說明(常見問題)

圖資館首頁

登入

回首頁

切換: 標籤 | MARC模式 | ISBD

Biomedical product developmentbench ...

Arjmand, Babak.

Biomedical product developmentbench to bedside /

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Biomedical product developmentedited by Babak Arjmand, Moloud Payab, Parisa Goodarzi.
其他題名:	bench to bedside /
其他作者:	Arjmand, Babak.
出版者:	Cham :Springer International Publishing :2020.
面頁冊數:	xiv, 157 p. :ill., digital ;24 cm.
Contained By:	Springer eBooks
標題:	Biomedical engineering.
電子資源:	https://doi.org/10.1007/978-3-030-35626-2
ISBN:	9783030356262$q(electronic bk.)

Biomedical product developmentbench to bedside /
Biomedical product developmentbench to bedside /[electronic resource] :edited by Babak Arjmand, Moloud Payab, Parisa Goodarzi. - Cham :Springer International Publishing :2020. - xiv, 157 p. :ill., digital ;24 cm. - Learning materials in biosciences,2509-6125. - Learning materials in biosciences..

1. 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.

This 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.

ISBN: 9783030356262$q(electronic bk.)

Standard No.: 10.1007/978-3-030-35626-2doiSubjects--Topical Terms:

190330
Biomedical engineering.

LC Class. No.: R856 / .B566 2020

Dewey Class. No.: 610.28

Biomedical product developmentbench to bedside /
LDR:03140nmm a2200337 a 4500 001 574627
003 DE-He213
005 20200707164038.0
006 m d
007 cr nn 008maaau
008 201016s2020 sz s 0 eng d
020 $a 9783030356262$q(electronic bk.)
020 $a 9783030356255$q(paper)
024 7 $a 10.1007/978-3-030-35626-2 $2 doi
035 $a 978-3-030-35626-2
040 $a GP $c GP
041 0 $a eng
050 4 $a R856 $b .B566 2020
072 7 $a MQW $2 bicssc
072 7 $a MED003040 $2 bisacsh
072 7 $a MQW $2 thema
082 0 4 $a 610.28 $2 23
090 $a R856 $b .B615 2020
245 0 0 $a Biomedical product development $h [electronic resource] : $b bench to bedside / $c edited by Babak Arjmand, Moloud Payab, Parisa Goodarzi.
260 $a Cham : $b Springer International Publishing : $b Imprint: Springer, $c 2020.
300 $a xiv, 157 p. : $b ill., digital ; $c 24 cm.
490 1 $a Learning materials in biosciences, $x 2509-6125
505 0 $a 1. 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 $a This 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 $a Biomedical engineering. $3 190330
650 1 4 $a Biomedical Engineering/Biotechnology. $3 730838
650 2 4 $a Regenerative Medicine/Tissue Engineering. $3 675875
650 2 4 $a Medicine/Public Health, general. $3 273879
650 2 4 $a Biomedical Engineering and Bioengineering. $3 826326
650 2 4 $a Pharmaceutical Sciences/Technology. $3 338426
650 2 4 $a Biotechnology. $3 188829
700 1 $a Arjmand, Babak. $3 764164
700 1 $a Payab, Moloud. $3 862356
700 1 $a Goodarzi, Parisa. $3 862357
710 2 $a SpringerLink (Online service) $3 273601
773 0 $t Springer eBooks
830 0 $a Learning materials in biosciences. $3 759760
856 4 0 $u https://doi.org/10.1007/978-3-030-35626-2
950 $a Biomedical and Life Sciences (Springer-11642)