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 |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Medical device Computer science Best practice Alternatives to animal testing 02 engineering and technology In Vitro Techniques Animal Testing Alternatives 03 medical and health sciences ddc:570 Toxicity Tests Animals Humans Pace Pharmacology Research Attendance General Medicine 021001 nanoscience & nanotechnology Test (assessment) Medical Laboratory Technology in vitro testing refinement skin sensitization threshold of toxicological concern (TTC) nanotoxicology 030104 developmental biology Equipment and Supplies Risk analysis (engineering) Paradigm shift Animal Testing Alternative 0210 nano-technology |
| Zdroj: | ALTEX. :479-500 |
| ISSN: | 1868-596X |
| Popis: | 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 reliable than in vivo testing. Although the technological landscape has evolved rapidly in support of these concepts, regulatory acceptance of alternative testing methods has not kept pace. Despite the acceptance by regulators of some in vitro tests (cytotoxicity, gene toxicity, and some hemocompatibility assays), many toxicity tests still rely on animals (irritation, sensitization, acute toxicity, reproductive/developmental toxicity), even where other industrial sectors have already abandoned them. Bringing about change will require a paradigm shift in current approaches to testing - and a concerted effort to generate better data on risks to human health from exposure to leachable chemicals from medical devices, and to boost confidence in the use of alternative methods to test devices. To help advance these ideas, stir debate about best practices, and coalesce around a roadmap forward, the JHU-Center for Alternatives to Animal Testing (CAAT) hosted a symposium believed to be the first gathering dedicated to the topic of in vitro testing of medical devices. Industry representatives, academics, and regulators in attendance presented evidence to support the unique strengths and challenges associated with the approaches currently in use as well as new methods under development, and drew next steps to push the field forward from their presentations and discussion. published |
| Databáze: | OpenAIRE |
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