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Monthly Archives: February 2015

Share on Google+ February 23, 2015

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Out of Control Cholesterol – The Watanabe Rabbit as an Animal Model of Familial Hypercholesterolemia

Category : APS Service Offerings, Watanabe Rabbits

What is the Watanabe Rabbit:  The Watanabe Heritable Hyperlipidemic (WHHL-MI) rabbit is an animal model of familial hypercholesterolemia, which is caused by a genetic and functional deficiency in low-density lipoprotein receptors.  This leads to a significant increase in serum cholesterol as compared to normal animals and in this sub-strain, a propensity to develop myocardial infarction.     This sample of

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Share on Google+ February 17, 2015

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No Surprises: Pre-Study meetings with Regulatory Agencies for Pivotal GLP studies

Category : Uncategorized

The recent FDA Guidance Document: Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies, issued in October of 2013 the Agency states: “Discussions with FDA on study protocols, including the evaluation of operator technique, safety outcomes, and the effects of the biological system on the device, are encouraged prior to the

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