Non Animal Testing, Alternative Test Methods, In Vitro Toxicology, IIVS | Erin Hill
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Erin Hill Tag

IIVS Collaborates with BASF and Givaudan to Validate a Non-animal Test for Regulatory Submissions

August 28, 2018
GAITHERSBURG, MD –August 28– The Institute for In Vitro Sciences (IIVS), with an established track record in the validation of alternatives to animal testing, is teaming up with BASF and Givaudan to validate an improved skin sensitization reactivity method to address the needs of toxicologists and regulators. Scientists at BASF and Givaudan have developed the Kinetic Direct Peptide Reactivity Assay (Kinetic DPRA), a non-animal test to predict allergic reactions in the skin known as sensitization. Three other non-animal sensitizer tests have...

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,  regulator 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...