Non Animal Testing, Alternative Test Methods, In Vitro Toxicology, IIVS | Assays Vaginal Irritation
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Archive

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....

Collaborative Effort Aims to Replace Rabbit Test for Personal Lubricant Products

August 21, 2017
Study in Response to Consumer Demands for Humane Testing Washington, D.C. — August 21, 2017 — A first-of-its kind collaborative project is underway to find a non-animal test method to replace the rabbit vaginal irritation test for personal lubricants. The U.S. Food and Drug Administration (FDA) gave the project a green light as part of the agency’s program aimed at modernizing the tests used to develop and evaluate medical devices. The work of the lubricant industry, the Institute for In Vitro Sciences...

Webinar: How GLPs Enhance the Quality of Regulated and Non-Regulated Toxicology

October 18, 2016
This one-hour webinar, led by IIVS Director of Quality and Compliance, introduces some of the concepts of Good Laboratory Practices (GLPs) designed to promote study and data integrity within an in vitro toxicology framework. Applying these concepts within your own laboratory should aid in production of robust, repeatable studies. View Slides...

Vaginal Irritation

August 24, 2016
The irritation potential of pharmaceutical, cosmetic and personal care products that are specifically formulated for application onto human mucosal tissues is evaluated using reconstructed tissue models such as EpiVaginal™ (MatTek Corporation, Ashland, MA, USA) or the Human Vaginal Epithelium (HVE) (EpiSkin, Lyon, France). The toxicity is determined by measuring the relative viability of the tissues treated with the test materials and compared to the negative/solvent control-treated tissues. The safety of the pharmaceutical, cosmetic and personal care products that are specifically formulated...