scholarly journals Pre-validation of an in vitro skin irritation test for medical devices using the reconstructed human tissue model EpiDerm™

2018 ◽  
Vol 50 ◽  
pp. 407-417 ◽  
Author(s):  
Helena Kandarova ◽  
Jamin A. Willoughby ◽  
Wim H. De Jong ◽  
Silvia Letasiova ◽  
Tatiana Milasova ◽  
...  
Keyword(s):  
Medical Devices ◽  
Human Tissue ◽  
Skin Irritation ◽  
Tissue Model ◽  
Irritation Test ◽  
Skin Irritation Test

Development, optimization and standardization of an in vitro skin irritation test for medical devices using the reconstructed human tissue model epiderm

2015 ◽  
Vol 238 (2) ◽  
pp. S351-S352 ◽  
Author(s):  
H. Kandarova ◽  
J. Willoughby ◽  
W. de Jong ◽  
M. Bachelor ◽  
S. Letasiova ◽  
...  
Keyword(s):  
Medical Devices ◽  
Human Tissue ◽  
Skin Irritation ◽  
Tissue Model ◽  
Irritation Test ◽  
Skin Irritation Test

Development, optimization and validation of an in vitro skin irritation test for medical devices using the reconstructed human tissue model EpiDerm

2016 ◽  
Vol 258 ◽  
pp. S63
Author(s):  
H. Kandarova ◽  
J.A. Willoughby ◽  
W.H. De Jong ◽  
M.A. Bachelor ◽  
S. Letasiova ◽  
...  
Keyword(s):  
Medical Devices ◽  
Human Tissue ◽  
Skin Irritation ◽  
Tissue Model ◽  
Irritation Test ◽  
Skin Irritation Test

Round robin study to evaluate the Reconstructed Human Epidermis model as an in vitro skin irritation test for medical devices

2017 ◽  
Vol 280 ◽  
pp. S278
Author(s):  
Kelly Coleman ◽  
Wim De Jong ◽  
Sebastian Hoffmann ◽  
Michelle Lee ◽  
Helena Kandarova ◽  
...  
Keyword(s):  
Medical Devices ◽  
Skin Irritation ◽  
Round Robin ◽  
Human Epidermis ◽  
Reconstructed Human Epidermis ◽  
Irritation Test ◽  
Skin Irritation Test

Optimized Preparation of Capsaicin-Loaded Nanoparticles Gel by Box-Behnken Design

2014 ◽  
Vol 1061-1062 ◽  
pp. 359-368 ◽  
Author(s):  
Mei Ling Tang ◽  
Li Hua Chen ◽  
Dong Sheng Zhou ◽  
Wei Feng Zhu ◽  
Yong Mei Guan ◽  
...  
Keyword(s):  
Skin Permeation ◽  
Skin Irritation ◽  
Morphological Characteristics ◽  
Entrapment Efficiency ◽  
Box Behnken Design ◽  
Irritation Test ◽  
Predicted Values ◽  
Skin Irritation Test

A three-factor three-level Box-Behnken design(BBD) was employed to optimize capsaicin-loaded nanoparticles(Cap-NPs), and its properties in vitro and in vivo were evaluated. Particle size, morphological characteristics, entrapment efficiency of Cap-NPs were investigated respectively by Zetasizer, H7000 TEM and HPLC. Release, skin permeation and skin irritation test were investigated on mouse and rabbits. The predicted values of Cap-NPs were 94.50±6.33% for entrapment efficiency(EE) and 170.30±7.81 nm for particle mean diameter(PMD) under optimal conditions which were 346.33 bar (homogenization pressure, X1), 4.67 min(homogenization time, X2), and 15421.42 rpm (shear rate, X3). The in vitro permeation study showed that capsaicin permeability in NPs-gel was a 2.80-fold greater flux values than conventional ointment after 24 h. Cap-NPs-gel produce no observable skin irritation in rabbits within 72h. The optimized Cap-NPs-gel would be a good candidate for transdermal delivery.

In vitro skin irritation test: Increasing the sensitivity of the EpiDerm skin irritation protocol evaluated in the ECVAM skin irritation validation study

2007 ◽  
Vol 172 ◽  
pp. S81 ◽  
Author(s):  
Helena Kandárová ◽  
Patrick Hayden ◽  
Erin Spiller ◽  
Mitch Klausner ◽  
Joseph Kubilus ◽  
...  
Keyword(s):  
Validation Study ◽  
Skin Irritation ◽  
Irritation Test ◽  
Skin Irritation Test
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