Round Robin Study for Evaluation an in vitro skin irritation test for medical device extracts using KeraSkinTM in Korea

Author:

Kim JoohwanORCID,Kang Nam-HeeORCID,Kim Jin Sik,Kim Il Soo,Kim Younhee

Funder

Ministry of Food and Drug Safety

Publisher

Elsevier BV

Reference16 articles.

1. Guidelines, criteria, and rules of thumb for evaluating normed and standardized assessment instruments in psychology;Cicchetti;Psychol.,1994

2. Round robin study to evaluate the reconstructed human epidermis (RhE) model as an in vitro skin irritation test for detection of irritant activity in medical device extracts;De Jong;Toxicol. Vitro,2018

3. Me-too validation study for in vitro skin irritation test with a reconstructed human epidermis model, KeraSkinTM for OECD test guideline 439;Han;Regul. Toxicol. Pharmacol.,2020

4. Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process,2019

5. Biological Evaluation of Medical Devices – Part 12: Sample Preparation and Reference Materials,2021

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