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Posters & Presentations

Quality Considerations: Redefining Test Systems from Animals to Tissues and Beyond

August 28, 2017

Presented at the 2017 World Congress on Alternatives and Animals in the Life Sciences (WC10) A.K. Ulrey, RQAP-GLP; H.A. Raabe, M.S. The use of non-whole animal test methods transforms the way regulatory requirements are applied in preclinical testing. Recent global regulatory initiatives emphasize the importance of transitioning to human relevant assays and test systems that do not use animals. When these methods are moved from research into the regulated arena, GLP principles must be followed. The GLPs were originally written in the 1970s, when the vast majority of regulated research was performed using animals as the test system. Current innovative, alternative test systems include ex vivo tissues, manufactured biological systems, three dimensional tissue constructs, and cell cultures maintained in dynamic flow bioreactors. Each type of alternative test system raises new quality and compliance points to consider when used within a regulatory context. Just as the applications of these methods have advanced with regulatory acceptance, the quality control and compliance of these test systems must also progress.

Introducing the 3R Concepts into Pre-College Classrooms

August 28, 2017

Presented at the 2017 World Congress on Alternatives and Animals in the Life Sciences (WC10)

N. Green, G.-E. Costin, A. Miller, S. Leary, K. Lewis    This poster provides a snapshot of precollege teachers (46) within the U.S.—gauging their knowledge and familiarity of the 3Rs and non-animal testing methods (i.e. in vitro methods), initiative to address the topic in the classroom, and their students’ level of interest in the topic. While recognizing the ethical considerations related to animal experimentation, the current generation of teachers and students are also eager to understand the relevance, reliability, and reproducibility of in vitro methods as the modern wave of technologies in toxicology, and possible replacement of animal use for testing purposes. Our data indicate an education field eager to learn about new concepts that might impact our daily activities in an ethical way, and to get up to speed with advances in science.

Non-Animal Testing Approach to Address Biocompatibility Testing of Medical Devices Required by the United States Food and Drug Administration (US FDA)

August 28, 2017

Presented at the 2017 World Congress on Alternatives and Animals in the Life Sciences (WC10)

E. Hill, R. Curren, and G.-E. Costin Starting in December 2015, personal lubricants must receive pre-market approval from the US FDA Center for Devices and Radiological Health (CDRH) in order to be sold in the US. Part of the testing battery for biocompatibility includes the in vivo Rabbit Vaginal Irritation (RVI) test. We have created an Industry Consortium comprised of personal lubricants manufacturers and are working collaboratively with stakeholders and the US FDA to develop an in vitro testing approach to substitute for the RVI. Our Validation Program will analyze paired in vivo-in vitro data for vaginal irritation utilizing commercially available human reconstructed vaginal tissue models. A Prediction Model will be proposed that can be used for the safety assessment of personal lubricants. Our Validation Program proposal has been accepted in the Incubator Phase of the US FDA Medical Device Development Tool (MDDT) Pilot Program and is currently ongoing.

In Vitro Models Available for Testing of ENDS

February 20, 2017

Presented at the National Academies of Sciences, Engineering, and Medicine's (NAS) workshop on electronic nicotine delivery systems (ENDS), e-cigarettes.

Case Study: Applying GLPs to New, Non-Animal Methodologies

January 26, 2017

2nd Good Laboratory Practice Compliance Summit