Key challenges for in vitro testing of oral tobacco and nicotine products for regulatory applications: Recommendations for using in vitro toxicity and disease models
Abstract
The Institute for In Vitro Sciences (IIVS) has sponsored a series of workshops with the aim of developing recommendations for scientific and technical approaches to conducting in vitro assays to assess potential toxicity within and across tobacco and nicotine products. As well as providing a background overview of oral tobacco and nicotine products, this report focuses on the methods used to generate extracts from these products for in vitro testing, the recommended best testing practices, and suggested areas for future research. This publication was developed by a working group of workshop members, in conjunction with the ninth IIVS in vitro workshop entitled ‘ In Vitro Models for Testing Oral Tobacco and Nicotine Products and Continued Discussion of In Vitro Models of Toxicity and Disease ’, which was held in January 2024.
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Authors: Emma Bishop, Katarina Aleksa, Damien Breheny, Samuel Constant, Jeremie Gafner, Sara Hurtado, M. Hollings, Brian M. Keyser, Mitchell Klausner, Robert Leverette, Lynn McFadden, Jacqueline Miller‐Holt, Martha M. Moore, Sara Moses, Hans Raabe, Mariano Scian, Kristie Sullivan, Leon F. Stankowski, Rana Tayyarah, Roman Wieczorek, Rodger Curren
Institutions: Nutrition International, Research Applications (United States), British American Tobacco (Germany), Exelixis (United States), Centre for Innovation in Regulatory Science, Altria (United States), Harrogate District Hospital, MatTek Corporation (United States), Ashland (United States), Orthopaedic Research of Virginia, Martel, Institute for In Vitro Sciences, Charles River Laboratories (United States), Imperial Brands (United Kingdom)