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APS researcher breaks down the challenges of ISO 10993 for E&L device testing

It’s commonplace in the CRO community: While researchers recognize the value of strict FDA rules set for biocompatibility testing, they’re continually frustrated by ISO stipulations that aren’t necessarily relevant when evaluating implantable medical devices. That means the researchers often spend unnecessary time and money on extractable and leachable (E&L) testing procedures that don’t result in […]

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The importance of rigorous ACT management during preclinical study procedures

During the preclinical testing of medical devices, one data point that regulatory officials are scrutinizing is the activated clotting time (ACT) of the animal model. ACTs are measured periodically while an invasive device is inserted in the vasculature This allows lab staff to monitor clotting time before and after the anti-coagulant (e.g. heparin) has been […]

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FAQs: Key facts to know about APS’s preclinical animal models

Whether you’ve contracted for pre-clinical testing before or you’re approaching the process for the first time, you may have key questions about APS’s preclinical animal models and testing capabilities. The scientific community understands the vital importance of conducting the crucial pre-clinical tests before risking similar testing on humans. Through the years animal research has led […]

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APS welcomes new Director of Toxicology, Dr. Harriet Kamendi

Dr. Harriet Kamendi is a graduate of Howard University’s Department of Pharmacology. Her research focused on characterizing the consequences of nicotine addiction on cardiovascular function using molecular and  pharmacological tools to characterize the expression and regulation of nicotinic acetylcholine receptors in cardiovascular control centers of the brain. Following graduation she pursued postdoctoral studies at George […]

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