The suitability of reconstructed human epidermis models for medical device irritation assessment: A comparison of In Vitro and In Vivo testing results

Autor: Kelly P Coleman, Chenghu Liu, Jia Liu, Wim H. de Jong, Chunguang Fan, Audrey P. Turley, Thor S. Rollins, Joseph W. Carraway

The ISO 10993 standards on biocompatibility assessment of medical devices discourage the use of animal tests when reliable and validated in vitro methods are available. A round robin validation study of in vitro reconstructed human epidermis (RhE) as

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5710a9f8633b162c61eb8d846c59ba54
http://hdl.handle.net/10029/624385

List of Contributors

Autor: Abhinav Acharya, Marian A. Ackun-Farmmer, John R. Aggas, Phillip J. Andersen, James M. Anderson, Kristi Anseth, Paul A. Archer, Nureddin Ashammakhi, Jose D. Avila, Julia E. Babensee, Stephen f. Badylak, Kiheon Baek, Aaron B. Baker, Syeda Mahwish Bakht, Amit Bandyopadhyay, Aaron Barchowsky, Garrett Bass, Matthew L. Becker, Sarah Miho Van Belleghem, Danielle S.W. Benoit, Arne Biesiekierski, Kristen L. Billiar, Susmita Bose, Christopher Bowman, Steven Boyce, Bryan N. Brown, Justin L. Brown, Jeffrey R. Capadona, David G. Castner, Calvin Chang, Philip Chang, Ashutosh Chilkoti, Karen L. Christman, Sangwon Chung, Kelly P. Coleman, Dan Conway, Keith E. Cook, Stuart L. Cooper, Elizabeth Cosgriff-Hernandez, Arthur J. Coury, Joseph D. Criscione, Heidi Culver, Jim Curtis, Feiyang Deng, Prachi Dhavalikar, Luis Diaz-Gomez, Rui M.A. Domingues, Elaine Duncan, Pamela Duran, Pedro Esbrit, Suzanne G. Eskin, Michael Y. Esmail, Jack L. Ferracane, Claudia Fischbach, Gary Fischman, John P. Fisher, Iolanda Francolini, Steven J. Frey, Akhilesh K. Gaharwar, Andrés J. García, Iain R. Gibson, Jeremy L. Gilbert, Brian Ginn, Zachary E. Goldblatt, Seth J. Goldenberg, Manuela E. Gomes, Manuel Gómez-Florit, Inês C. Gonçalves, Maud B. Gorbet, David W. Grainger, Miles Grody, Teja Guda, Scott A. Guelcher, Anthony Guiseppi-Elie, S. Adam Hacking, Nadim James Hallab, Luanne Hall-Stoodley, Stephen R. Hanson, Woojin M. Han, Melinda K. Harman, Roger Harrington, Martin J. Haschak, Daniel E. Heath, Emily Anne Hicks, Ryan T. Hill, Allan S. Hoffman, Thomas A. Horbett, Jeffrey A. Hubbell, Rasim Ipek, Joshua J. Jacobs, Young C. Jang, Shaoyi Jiang, Richard J. Johnson, Julian R. Jones, Vickie Y. Jo, Ravi S. Kane, David L. Kaplan, Ronit Kar, Benjamin George Keselowsky, Ali Khademhosseini, Yu Seon Kim, Martin W. King, Daniel S. Kohane, David H. Kohn, Liisa T. Kuhn, Mangesh Kulkarni, Catherine K. Kuo, Angela Lai, Bryron Lambert, Ziyang Lan, Robert A. Latour, Cato T. Laurencin, Bryan K. Lawson, Shannon Lee Layland, Jae Sung Lee, David Lee-Parritz, Ying Lei, Jack E. Lemons, Robert J. Levy, Gregory M. Lewerenz, Jamal S. Lewis, Simone Liebscher, Chien-Chi Lin, Natalie K. Livingston, Yang Li, Yuncang Li, Helen Lu, Laura Macdougall, Bhushan Mahadik, Sachin Mamidwar, Margaret P. Manspeaker, Hai-Quan Mao, Peter X. Ma, Tyler Marcet, Jeffrey Martin, M. Cristina L. Martins, Sally L. McArthur, Meghan McGill, Larry V. McIntire, Lei Mei, Bárbara B. Mendes, Antonios G. Mikos, Richard N. Mitchell, Indranath Mitra, Ben Muirhead, Khurram Munir, William L. Murphy, Phong K. Nguyen, Alexis L. Nolfi, Clyde Overby, Sertan Ozan, Robert F. Padera, Hannah A. Pearce, Nicholas A. Peppas, Andreia T. Pereira, Carmem S. Pfeifer, Artur M. Pinto, Nicole R. Raia, Edward A. Rankin, Buddy D. Ratner, Maria Vallet Regi, Rui L. Reis, Alastair Campbell Ritchie, Shelly E. Sakiyama-Elbert, Karim Salhadar, Antonio J. Salinas, Katja Schenke-Layland, Frederick J. Schoen, Brittany E. Schutrum, Michael V. Sefton, Michael A. Seidman, Darshan S. Shah, Heather Sheardown, Andrew J. Shoffstall, Carl G. Simon, Josh Simon, Kenneth R. Sims Jr., Steven M. Slack, Benjamin Slavin, Kirstie Lane Snodderly, Patrick S. Stayton, Stephanie D. Steichen, Paul Stoodley, W. Benton Swanson, Hobey Tam, Aftab Tayab, Susan N. Thomas, Kellen D. Traxel, Rocky S. Tuan, Erik I. Tucker, Rei Ukita, Austin Veith, Sarah E. Vidal Yucha, Christopher Viney, Naren Vyavahare, William R. Wagner, Min Wang, Raymond M. Wang, Petra Warner, Cuie Wen, Jennifer L. West, Matthew A. Whitman, Frank Witte, Michael F. Wolf, Zhicheng Yao, Michael Yaszemski, Michael J. Yaszemski, Lichen Yin, Guigen Zhang, Peng Zhang, Zhiyuan Zhong, Nicholas P. Ziats

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::50c363cb2f9f6018483ab37fc67e9199
https://doi.org/10.1016/b978-0-12-816137-1.01002-3

From in vivo to in vitro: The medical device testing paradigm shift

Autor: Anthony Bahinski, Dayna Kerecman Myers, Albrecht Poth, Joseph W. Carraway, Richard Hutchinson, Harald F. Krug, Alan M. Goldberg, Ronald P. Brown, Kelly P Coleman, Thomas Hartung, Michael F. Wolf, James M. McKim

Publikováno v: ALTEX. :479-500

Amid growing efforts to advance the replacement, reduction, and refinement of the use of animals in research, there is a growing recognition that in vitro testing of medical devices can be more effective, both in terms of cost and time, and also more

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::43abff4d602325bd18142a4090348cbb
https://doi.org/10.14573/altex.1608081

Preparation of irritant polymer samples for an in vitro round robin study

Autor: Lori R. McNamara, Kelly P. Coleman, Beau Rollins, Nicholas J. Christiano, Thomas P. Grailer, Helena Kandarova, Wim H. de Jong

A round robin study using reconstructed human epidermis (RhE) tissues was conducted to test medical device polymer extracts for skin irritation potential. Test samples were four irritant and three non-irritant medical device polymers. Five of these p

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a4a6d6cffeb2520b0e4dc21704bd7e4b
http://hdl.handle.net/10029/621411

Evaluation of anIn VitroHuman Dermal Sensitization Test for Use with Medical Device Extracts

Autor: Lori R. McNamara, Jamin A. Willoughby, Thomas P. Grailer, Kelly P. Coleman, Prakash Patel, Clive Dilworth, Donald J. Keller, Simon Thomas

Publikováno v: Applied In Vitro Toxicology. 1:118-130

In accordance with ISO 10993-10, the guinea pig maximization test, Buehler test, or murine local lymph node assay are used to assess the dermal sensitization potential of medical devices. The goal of our study was to determine if the in vitro SenCeeT

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::c5d7e23fbc8e18e1f68110952a0a9935
https://doi.org/10.1089/aivt.2015.0007