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Tag Archives: preclinical research

Share on Google+ July 10, 2017

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Pathology Matters, part 2 of a 3 part series: Assessing Histopathology Results

Category : Histopathology, Interventional Medicine, Medical Device testing

Part 1 of this series described the preclinical study types relying heavily on histopathology data: device safety, biocompatibility, and systemic toxicity. Here we focus on strategies for histopathology data assessment. Preclinical study histopathology data can generally be divided into three types: Qualitative Quantitative Semiquantitative Qualitative histopathology uses description to document tissue changes and is more applicable to studies where the

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Share on Google+ June 12, 2017

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Pathology Matters, part 1 of a 3 part series: Preclinical Studies and Histopathology

Category : Histopathology, Interventional Medicine, ISO, Medical Device testing

The histopathology evaluation in preclinical studies is performed to support the study objectives. The study type, tissues examined, and intended data use all determine what pathology analysis is needed. Here we review the preclinical studies that rely heavily on histopathology data. Histopathology is a key component of these preclinical study types: Device safety studies Biocompatibility studies Systemic toxicity studies These

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Share on Google+ September 18, 2015

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New Directions in ISO-10993-4 Hemocompatibility Testing of Medical Devices

Category : ISO

Don’t miss Kent Grove on Tuesday 9/22/15 at the 25th Annual BioInterface Workshop & Symposium. Kent will be discussing new updates in both in vivo and in vitro hemocompatibility and thrombogenicity testing. Kent was an invited speaker at the FDA workshop on Methods for Thrombogenicity Testing, held on April 14, 2014.  Kent has also championed a new minimally heparinized in

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Share on Google+ September 9, 2015

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APS Publishes First Guidance Document: Recommendations for the Evaluation of Investigational Heart Valves

Category : Cardiology

Scope: This guidance applies to both surgical and percutaneous delivered heart valves and other valve repair technologies. Experience:  APS conducts 150+ non-GLP/GLP valve repair or replacement procedures per year. Imaging:  APS has three Siemens digital cath lab suites, an experienced echocardiographer and a 128-slice Siemens Dual Source CT scanner. APS publishes the first in a series of preclinical research guidance documents

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Share on Google+ August 18, 2015

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BioInterface Conference Coming to Arizona

Category : ISO

The 2015 Biolnterface Conference is the hallmark annual event of the Surfaces in Biomaterials Foundation (SIBF). This year’s conference – the 25th Anniversary of the event – is scheduled for September 21-23 at the Fairmont Scottsdale Princess in Arizona. The BioInterface Conference kicks off with Workshops on Monday, Sept. 21. The theme of this year’s Workshops is Hemocompatibility Technologies, Models

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Share on Google+ August 13, 2015

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Quality Makes the Difference

Category : Uncategorized

American Preclinical Services believes that quality makes the difference and our approach is what sets us apart. At APS, quality is collaboration between all APS employees. We are continually working as a team to monitor quality, identify areas for improvement, implement solutions and improve quality. See What Sets Us Apart! Weekly operations and scientific meetings to review study initiation and

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