Literature DB >> 14623408

Global regulatory registration requirements for collagen-based combination products: points to consider.

Judith E O'Grady1, Diana M Bordon.   

Abstract

Collagen-based medical products provide an ideal and unique matrix for the delivery of drugs, biologics and other therapeutic agents. Collagen has a long history of safety and effectiveness. Collagen is biodegradable with minimal tissue reaction. Regulatory requirements for approval of collagen-based combination products are changing as more high technology combinations are developed. There are special considerations that need to be addressed for collagen products. Products of animal origin must meet specific requirements in regards to safety factors regarding Transmissable Spongiform Encephalopathies. Global regulatory registration requirements and special controls are presented.

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Year:  2003        PMID： 14623408     DOI： 10.1016/j.addr.2003.08.006

Source DB:  PubMed          Journal:  Adv Drug Deliv Rev        ISSN： 0169-409X            Impact factor:   15.470


  7 in total

Review 1.  Designed triple-helical peptides as tools for collagen biochemistry and matrix engineering.

Authors:  Takaki Koide
Journal:  Philos Trans R Soc Lond B Biol Sci       Date:  2007-08-29       Impact factor: 6.237

2.  Next Generation Mesenchymal Stem Cell (MSC)-Based Cartilage Repair Using Scaffold-Free Tissue Engineered Constructs Generated with Synovial Mesenchymal Stem Cells.

Authors:  Kazunori Shimomura; Wataru Ando; Yu Moriguchi; Norihiko Sugita; Yukihiko Yasui; Kota Koizumi; Hiromichi Fujie; David A Hart; Hideki Yoshikawa; Norimasa Nakamura
Journal:  Cartilage       Date:  2015-03-24       Impact factor: 4.634

3.  In vitro targeted magnetic delivery and tracking of superparamagnetic iron oxide particles labeled stem cells for articular cartilage defect repair.

Authors:  Yong Feng; Xuhong Jin; Gang Dai; Jun Liu; Jiarong Chen; Liu Yang
Journal:  J Huazhong Univ Sci Technolog Med Sci       Date:  2011-04-20

4.  Polyethyleneimine-grafted collagen fiber as a carrier for cell immobilization.

Authors:  Deyi Zhu; Xia Li; Xuepin Liao; Bi Shi
Journal:  J Ind Microbiol Biotechnol       Date:  2014-12-25       Impact factor: 3.346

5.  Compositional control of higher order assembly using synthetic collagen peptides.

Authors:  Fei Xu; Ji Li; Vikas Jain; Raymond S Tu; Qingrong Huang; Vikas Nanda
Journal:  J Am Chem Soc       Date:  2011-12-21       Impact factor: 15.419

6.  Self-assembly of left- and right-handed molecular screws.

Authors:  Fei Xu; I John Khan; Kenneth McGuinness; Avanish S Parmar; Teresita Silva; N Sanjeeva Murthy; Vikas Nanda
Journal:  J Am Chem Soc       Date:  2013-12-03       Impact factor: 15.419

7.  Transplantation of a Scaffold-Free Cartilage Tissue Analogue for the Treatment of Physeal Cartilage Injury of the Proximal Tibia in Rabbits.

Authors:  Sang Uk Lee; Jae Young Lee; Sun Young Joo; Yong Suk Lee; Changhoon Jeong
Journal:  Yonsei Med J       Date:  2016-03       Impact factor: 2.759
  7 in total

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