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

Non-animal Vaginal Irritation Method Admitted into the US FDA Medical Devices Development Tool (MDDT)

October 18, 2018
FDA’s recently launched Predictive Toxicology Roadmap calls for the optimization of non-animal methods for the safety evaluation of drugs, consumer products and medical devices. We have created an Industry Consortium comprised of manufacturers of personal lubricants/vaginal moisturizers and companies interested in the advancement of animal alternatives working collaboratively with stakeholders and the US FDA to develop an in vitro testing approach that could be used in place of the rabbit vaginal irritation (RVI) in pre-market submissions....

How the Good In Vitro Method Practices Guidance Document Can Help Implement New Toxicological Approaches: A Case Study in China

October 17, 2018
Currently China is striving to adopt and implement non-animal, including in vitro, testing approaches for the safety assessment of cosmetics and ingredients.  Collaborative efforts between industry and the Institute for In Vitro Sciences (IIVS, Gaithersburg, USA) have focused on the transfer of several OECD Test Guideline methods to government laboratories in China and have supported the creation of an in vitro toxicology testing laboratory within the Zhejiang Institute for Food and Drug Control (Hangzhou, China).  Recently BASF SE (Ludwigshafen, Germany) and IIVS...

IIVS Appointed to China’s Alternatives Working Group for Cosmetics

October 9, 2018
Gaithersburg, MD – October 9, 2018 – U.S. based Institute for In Vitro Sciences (IIVS) has been invited by China’s National Institute for Food and Drug Control (NIFDC) to join their working group on alternatives for cosmetics.  The newly established group was announced by the NIFDC during their 2nd International Conference on Cosmetics Alternative Methods held in Beijing in September.  Chaired by NIFDC Vice Director, Lu Yong, the working group also includes representatives from several provincial government agencies and companies...

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, 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...