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Category Archives: Study Design Consulting

Share on Google+ April 27, 2015

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Selecting the Appropriate Animal Model for Medical Device Testing

Category : In-vivo Testing, Medical Device testing, Study Design Consulting

Selecting the appropriate animal model for medical device testing will be one of the most important decisions made during the period of study design. The animal model selected should be as representative as possible to the target patient population. The selection process requires thorough knowledge of each species anatomy and physiology. It is equally as important to understand how each

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Share on Google+ April 6, 2015

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Lost In Translation: The Use of Large Animal Disease Models in Preclinical Research

Category : APS Service Offerings, Study Design Consulting

Animal models of human disease have been used for decades by the pharmaceutical industry to confirm “proof-of-concept” for a molecular target or to evaluate the efficacy of new chemical entities or toxicity of a certain compound when used to treat the underlying condition.  Yet, for the medical device research and development community, the transition of these disease models into large

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Share on Google+ July 26, 2013

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All ISO 10993 Thrombo Study Designs Are Not Created Equal

Category : In-vitro testing, In-vivo Testing, Study Design Consulting, Study Management

The in-vivo thrombogenicity assay is a widely used method for screening the ability of blood contacting medical devices to cause a clot upon implantation. The in-vivo thrombogenicity assay is designed to evaluate the thrombogenicity potential of a medical device in comparison to a predicate device already on the market. As medical devices continue to become more advanced, the clinical relevance

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