August 2017

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

August 28, 2017
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...

Introducing the 3R Concepts into Pre-College Classrooms

August 28, 2017
This poster provides a snapshot of pre-college 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...

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...