LEADER 05136nam 22007455 450 001 9910380744103321 005 20251116225344.0 010 $a3-030-35626-4 024 7 $a10.1007/978-3-030-35626-2 035 $a(CKB)4100000010480377 035 $a(DE-He213)978-3-030-35626-2 035 $a(MiAaPQ)EBC6114479 035 $a(PPN)242980767 035 $a(EXLCZ)994100000010480377 100 $a20200205d2020 u| 0 101 0 $aeng 135 $aurnn|008mamaa 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aBiomedical Product Development: Bench to Bedside /$fedited by Babak Arjmand, Moloud Payab, Parisa Goodarzi 205 $a1st ed. 2020. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2020. 215 $a1 online resource (XIV, 157 p. 16 illus. in color.) 225 1 $aLearning Materials in Biosciences,$x2509-6125 311 08$a3-030-35625-6 320 $aIncludes bibliographical references and index. 327 $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. 330 $aThis textbook covers all the steps in manufacturing a biomedical product from bench to bedside. It specifically focuses on quality assurance and management and explains the different good practice principles in the various phases of product development as well as how to fulfill them: Good laboratory practice, good manufacturing practice and good clinical practice. It provides readers with the know-how to design biomedical experiments to ensure quality and integrity, to plan and conduct standard preclinical studies and to assure the quality of the final manufactured biomedical products. Importantly, it also addresses ethical concerns and considerations. The book discusses the guidelines and ethical considerations for preclinical and clinical studies, to allow readers to identify safety concerns regarding biomedical products and to improve pre-clinical studies for the development of better products. This textbook is a valuable guide for biomedical students (B.Sc., M.S., and Ph.D. students) in the field of molecular medicine, medical biotechnology, stem cell research and related areas, as well as for professionals such as quality control staff, tissue bankers, policy-makers and health professionals. 410 0$aLearning Materials in Biosciences,$x2509-6125 606 $aBiomedical engineering 606 $aRegenerative medicine 606 $aTissue engineering 606 $aMedicine 606 $aPharmaceutical technology 606 $aBiotechnology 606 $aBiomedical Engineering/Biotechnology$3https://scigraph.springernature.com/ontologies/product-market-codes/B24000 606 $aRegenerative Medicine/Tissue Engineering$3https://scigraph.springernature.com/ontologies/product-market-codes/L16080 606 $aMedicine/Public Health, general$3https://scigraph.springernature.com/ontologies/product-market-codes/H00007 606 $aBiomedical Engineering and Bioengineering$3https://scigraph.springernature.com/ontologies/product-market-codes/T2700X 606 $aPharmaceutical Sciences/Technology$3https://scigraph.springernature.com/ontologies/product-market-codes/B21010 606 $aBiotechnology$3https://scigraph.springernature.com/ontologies/product-market-codes/C12002 615 0$aBiomedical engineering. 615 0$aRegenerative medicine. 615 0$aTissue engineering. 615 0$aMedicine. 615 0$aPharmaceutical technology. 615 0$aBiotechnology. 615 14$aBiomedical Engineering/Biotechnology. 615 24$aRegenerative Medicine/Tissue Engineering. 615 24$aMedicine/Public Health, general. 615 24$aBiomedical Engineering and Bioengineering. 615 24$aPharmaceutical Sciences/Technology. 615 24$aBiotechnology. 676 $a610.28 702 $aArjmand$b Babak$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aPayab$b Moloud$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aGoodarzi$b Parisa$4edt$4http://id.loc.gov/vocabulary/relators/edt 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910380744103321 996 $aBiomedical Product Development: Bench to Bedside$92523544 997 $aUNINA