Non Animal Testing, Alternative Test Methods, In Vitro Toxicology, IIVS | next generation product
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next generation product Tag

Next-Generation Tobacco and Nicotine Products: Substantiating Harm Reduction and Supporting Tobacco Regulatory Science

June 21, 2018
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...

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, 2018
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...

Human In Vitro Models for Respiratory Toxicology: Evaluation of Goblet Cell Hyperplasia, Mucus Production, and Ciliary Beating Assays

March 28, 2018
Robust 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...