Publications
Evaluating the Use of Predictive Models in Combination with In Vitro Assays
April 11, 2022IIVS 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…)
Use of alternative test methods in a tiered testing approach to address photoirritation potential of fragrance materials
January 3, 2022Happy 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.
How a GIVIMP Certification Program Can Increase Confidence in In Vitro Methods
April 20, 2021Regulatory 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 .
Acute Electronic Vapour Product Whole Aerosol Exposure of 3D Human Bronchial Tissue
March 2, 2021IIVS 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.
Tiered In Vitro Testing Strategy For Assessing The Ocular and Dermal Irritation/Corrosion Potential of Pharmaceutical Compounds
July 23, 2018Read 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.
Next-Generation Tobacco and Nicotine Products: Substantiating Harm Reduction and Supporting Tobacco Regulatory Science
June 21, 2018A 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.
Characterization of a Vitrocell VC1 Using Nicotine Dosimetry: An Essential Component Toward Standardized In Vitro Aerosol Exposure of Tobacco and Next Generation Nicotine Delivery Products
June 21, 2018The 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.
Know Your Skin Cells: III. The Melanocytes
February 1, 2018IIVS toxicologist and study director, Emilia Costin wrote about melanocytes, responsible for producing skin color for The Cosmetic Chemist. Read article
In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use
August 17, 2017In 2009, the passing of the Family Smoking Prevention and Tobacco Control Act facilitated the establishment of the FDA Center for Tobacco Products (CTP), and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed ‘modified risk’. On April 4-6, 2016, IIVS convened a workshop conference entitled, In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products, to bring together stakeholders representing regulatory agencies, academia and industry to address the research priorities articulated by the FDA CTP. This report includes the proceedings, recommendations, and outcome of the April 2016 technical workshop, including paths forward for developing and validating non-animal test methods for tobacco product smoke and next generation tobacco product aerosol/vapor exposures. Full article available to full and paid subscribers of ATLA.
Advances in Science: Next Generation of Lab Tools, Models and Testing Platforms Used in Predictive Toxicology
July 19, 2017Toxicology testing platforms represent the basis of the human health risk assessment process that determines whether a material or product may induce harm to humans upon exposure. Historically, safety assessment of raw ingredients or finished formulations has been performed using animal-based test methods (in vivo) that provide whole organism responses to toxicants. Due to the large number of products launched by industry continuously, modern toxicology shifted in recent years towards the use of novel, fast and reliable alternative methods, ranging from in silico to in chemico or in vitro, of which some are validated for regulatory purposes. The manuscript also addresses emerging technologies in the form of “organ/body-on-a-chip” platforms which announce to be instrumental in allowing alternative systems to in vivo models to assess systemic toxic effects induced by chemicals. Read the full article.