Non Animal Testing, Alternative Test Methods, In Vitro Toxicology, IIVS | Gertrude Emilia Costin
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Gertrude Emilia Costin Tag

Shipping Study to Evaluate the Performance of the LabCyte EPI-MODEL 24 Tissues for Use in the Skin Irritation Test (OECD TG 439) After Long-Haul Airfreight

March 18, 2019
It is recommended that an evaluation of the impact of shipping of Reconstructed human Epidermis (RhE) tissues be conducted especially after long-haul airfreight shipments. The OECD Test Guideline 439 (OECD TG 439), In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method, recommends that users do so by verifying the barrier properties of the tissues after receipt. In this study, LabCyte EPI-MODEL 24 tissues were received in the USA after an overnight shipment from Japan and were tested to evaluate their performance...

Non-animal Vaginal Irritation Method Admitted into the US FDA Medical Devices Development Tool (MDDT)

October 18, 2018
FDA’s recently launched Predictive Toxicology Roadmap calls for the optimization of non-animal methods for the safety evaluation of drugs, consumer products and medical devices. We have created an Industry Consortium comprised of manufacturers of personal lubricants/vaginal moisturizers and companies interested in the advancement of animal alternatives working collaboratively with stakeholders and the US FDA to develop an in vitro testing approach that could be used in place of the rabbit vaginal irritation (RVI) in pre-market submissions....