VitroScreen Seminar - Substance-based medical device qualification and classification: Pre-clinical approaches to mechanism of action
Main Article Content
Article Details

This work is licensed under a Creative Commons Attribution 4.0 International License.
Articles are distributed under the terms of the Creative Commons Attribution 4.0 International license (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the original work is appropriately cited (CC-BY). Copyright on any article in ALTEX is retained by the author(s).
dimensional human buccal oral mucosal model Toxicol In Vitro 87, 105519. doi:10.1016/j.tiv.2022.105519
Ayehuni, S., Wang, Y.-Y., Landry, T. et al. (2018). Hyperosmolal vaginal lubricants markedly reduce epithelial barrier T properties in a three-dimensional vaginal epithelium model. Toxicol Rep 5, 134-140. doi:10.1016/j.toxrep.2017.12.011
Casiraghi, A., Ranzini, F., Musazzi, U. M. et al. (2017). In vitro method to evaluate the barrier properties of medical devices for cutaneous use. Regul Toxicol Pharmacol 90, 42e50. doi:10.1016/j.yrtph.2017.08.007
Ceriotti, L., Buratti, P., Corazziari, E.C. et al. (2022). Protective mechanisms of liquid formulations for gastro-oesophageal reflux disease in a human reconstructed oesophageal epithelium model. Med Devices 15, 143-152. doi:10.2147/MDER.S363616
Leone, M. G. (2022). Medical devices made of substances: A new challenge. Front Drug Saf Regul 2, 952013. doi:10.3389/fdsfr.2022.952013
Meloni, M., Balzaretti, S. and Ceriotti, L. (2019). Medical devices biocompatibility assessment on HCE: Evidences of delayed cytotoxicity of preserved compared to preservative free eye drops. Regul Toxicol Pharmacol 106, 81-89. doi:10.1016/j.yrtph.2019.04.022
Meloni, M., Buratti, P., Carriero, F. et al. (2021). In vitro modelling of barrier impairment associated with gastro-oesophageal reflux disease (GERD). Clin Exp Gastroenterol 14, 361-373. doi:10.2147/CEG.S325346
Sica, V. P., Friberg, M. A., Teufel, A. G. et al. (2022). Safety assessment scheme for menstrual cups and application for the evaluation of a menstrual cup comprised of medical grade silicone. eBioMedicine 86, 104339. doi:10.1016/j.ebiom.2022.104339
Yang, S.-Y., Piao, Y.-Z, Kim, K.-M. et al. (2021). Cytokine release from organotypic human oral tissue following exposure to oral care product chemicals. J Korean Dent Sci 14, 51-60.
Yun, J. W., Hailian, Q., Na, Y. et al. (2016). Exploration and comparison of in vitro eye irritation tests with the ISO standard in vivo rabbit test for the evaluation of the ocular irritancy of contact lenses. Toxicol In Vitro 37, 79-87. doi:10.1016/j.tiv.2016.09.001