Archive
Non-animal Vaginal Irritation Method Admitted into the US FDA Medical Devices Development Tool (MDDT)
October 18, 2018FDA’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, 2017Study 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, 2016This 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, 2016The irritation potential of pharmaceutical, cosmetic and personal care products, medical devices and related consumables (such as lubricants)* that are formulated for application onto human cervical or vaginal tissues can be evaluated using reconstructed organotypic models representative of human ecto-cervical and vaginal tissue. These models overcome some of the disadvantages of monolayer culture by the presence of a barrier layer that permits the direct apical application of active ingredients and final formulations, including mixture, formulations and ingredients that are not...
Cytokine induction in the 3D EpiDerm™ skin model used as an in vitro preclinical screening tool for formulations with anti-inflammatory action
October 1, 2015Source: ASCCT 2015...
IN VITRO SAFETY PROFILE OF PERSONAL CARE PRODUCTS – USE OF AN IN VITRO TESTING PLATFORM BASED ON A RECONSTRUCTED VAGINAL TISSUE MODEL
March 25, 2014Source: SOT 2014...
Vaginal Irritation Models: The Current Status of Available Alternative and In Vitro Tests
January 1, 2011Alternatives to Laboratory Animals Read article....