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....
Human In Vitro Models for Respiratory Toxicology: Evaluation of Goblet Cell Hyperplasia, Mucus Production, and Ciliary Beating Assays
March 28, 2018Robust non-animal models and assays for pulmonary toxicology are required to make competent product development and risk assessments for new materials requiring toxicity testing. Three in vitro assays (goblet cell hyperplasia [GCH], ciliary beat frequency [CBF], and MUC5AC quantitation) were evaluated for performance and reproducibility. To assess these assays, 6 laboratories contributed data using a common protocol utilizing IL-13 as an inducer of adverse mucociliary-relevant tissue changes. MatTek EpiAirway™ and Epithelix MucilAir™ 3D tissue models were used to evaluate endpoints...
Oral Irritation Assessment of Electronic Liquids Using an In Vitro Oral Testing Model
March 28, 2018While data are still being collected and analyzed, there were at least 1,300 accidental electronic liquid (e-liquid) exposures reported as of 2013. Deaths have occurred as a result of ingestion of e-liquid with the effects being attributed primarily to nicotine. The Food and Drug Administration (FDA) sought to regulate e-liquid through the Tobacco Control Act passed in 2009. In 2014, the FDA issued its “Deeming” proposals for public comments, which covered e-liquid manufacturing; the Final Rule giving the FDA authority to...
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...
Oral – Gingival Screening
August 24, 2016The safety assessment of raw ingredients or finished products intended for human oral use or that can accidentally come in contact with humans’ oral tissues can be performed using in vitro testing platforms based on reconstructed tissue models. The oral irritation potential of oral care, pharmaceutical or tobacco products can be investigated using the tissue viability (%) as main endpoint in the evaluation of cytotoxicity. The potential oral/buccal irritation of raw ingredients or finished products can be assessed using commercially available...
Next Generation Tobacco Products
August 24, 2016IIVS has a long-standing history of working with various industries to help establish or utilize in vitro models for the prediction of risk and the assessment of products under development. With the Food and Drug Administration extending its authority to all tobacco products (including e-cigarettes, cigars, and hookah) the tobacco industry is faced with the task of assessing product safety for product development and regulatory submission. Further, the manufacture of tobacco products may entail risk to workers that come in...
Digital Dispensing onto 3D Airway Tissue: Delivery of Patterned, Picoliter Volumes for Direct Apical Surface Coverage with Precise Quantities of Test Material
April 4, 2016Source: In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacc…...