IIVS is pleased to announce the co-publication of several respiratory-based articles highlighting: the characterization and recommendations for non-animal techniques used to model mucociliary clearance in human-derived test systems, the dosimetry of tobacco products for in vitro testing and a third article covering the use of New Approach Methodologies to nicotine containing products in a regulatory environment.
Key Challenges for In Vitro Testing of Tobacco Products for Regulatory applications: Recommendations for Dosimetry
Ciliary Beat Frequency: Proceedings and Recommendations from a Multi-laboratory Ring Trial Using 3-D Reconstituted Human Airway Epithelium to Model Mucociliary ClearanceUse of New Approach Methodologies (NAMs) to Meet Regulatory Requirements for the Assessment of Tobacco and Other Nicotine-Containing Products
Thank you to all who visited our booth or poster sessions at the 2022 Society of Toxicology annual meeting. If you would like copies of any of the poster presented we now have them available to view online (more…)
IIVS is excited to announce the publication of 2 papers evaluating the use of predictive models in combination with in vitro assays to provide a quantitative assessment of skin sensitization potential. This work is presented Drs. Frank Gerberick (GF3 Consultancy, Chief Scientific Advisor to IIVS) and Andreas Natsch (Senior Research Fellow at Givaudan ) (more…)
Happy New Year! IIVS is pleased to greet 2022 with the announcement of a joint publication with the Research Institute for Fragrance Materials (RIFM) involving the evaluation of photoirritation potential of over 100 compounds. This effort, spanning the course of 7 years, involved a tiered testing approach with the application of 3 OECD test guidelines: TG 101, 432 and the recently accepted 498, which codifies the acceptance of Reconstructed human Epidermis as a model for assessing this endpoint. Read the full article here.
Regulatory bodies, validation authorities, method developers, and industry toxicologists realize the need to increase confidence in the scientific validity of novel in vitro methods – especially those being proposed for regulatory application .
IIVS is excited to have taken part in a new publication highlighting the use of non-animal methods to compare cellular and molecular responses of tobacco smoke and Electronic Vapor Product aerosols. Read and Download the open access article here.
Read our latest publication with Bristol-Myers Squibb regarding a tiered testing strategy for occupational hazards of pharmaceutical intermediates now published in the Cutaneous and Ocular Toxicology Journal. Irritation reactions are a frequently reported occupational illness. The potential adverse effects of pharmaceutical compounds (PCs) on employees' eyes and skin can now be assessed using validated in vitro methods. Our overall aim is to reduce animal testing by replacing the historically utilized in vivo test methods with validated in vitro test methods which accurately determine the ocular and dermal irritation/corrosion potential of PCs to inform worker safety within the pharmaceutical space. BMS and IIVS have therefore conceptualized and internally qualified a tiered in vitro testing strategy to inform occupational hazards regarding eye and skin irritation and corrosivity of PCs. which is based on three Organisation for Economic Co-operation and Development (OECD) in vitro methods (OECD TG 435, OECD TG 437, OECD TG 439.) Read the full article.
A framework for the assessment of novel next-generation tobacco and nicotine products with the potential to reduce health risks compared with cigarettes should integrate scientific studies incorporating nonclinical, clinical, and population studies approaches. These products should have lower emissions and exhibit reduced biological effects compared with those of cigarettes, ideally approaching those of smoking cessation. The products should also be acceptable cigarette alternatives for current smokers, while not appealing to nonsmokers or former smokers. Validating harm reduction and promoting regulatory acceptance of the assessment methods require a collaborative approach by industry, independent reviewers, the public health community, and regulatory agencies. This article summarizes the science and approaches applied and considered to substantiate tobacco harm reduction in the light of regulatory requirements. Read the full article.
The U.S. Food and Drug Administration has regulatory authority over tobacco products, including conventional cigarettes and next generation products (NGPs) such as e-cigarettes and tobacco heating products (THPs). There is a desire by the industry, regulators and animal protection organizations to incorporate non-animal test methods for tobacco product and NGP assessment. When assessing respiratory effects in vitro, reliable exposure systems that deliver aerosols to cellular/tissue cultures (such as human reconstructed airways or lung slices) at the air–liquid interface are needed. Using nicotine dosimetry, we report the characterization of a Vitrocell VC1 in our laboratories (IIVS, USA). Nicotine, generated from a 3R4F reference cigarette or NGP (e-cigarette and THP) aerosols at source and the exposure interface (culture media), was assessed using ultra-high-performance liquid chromatography–tandem mass spectrometry. These data were compared to published dosimetry data for the same products, generated at a different laboratory (BAT R&D, Southampton, UK), on different exposure systems (VC10 and Borgwaldt RM20S) to confirm repeatability. Read the full article.
IIVS toxicologist and study director, Emilia Costin wrote about melanocytes, responsible for producing skin color for The Cosmetic Chemist. Read article