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Experienced researchers and technicians are at your service when you partner with American Preclinical Services. You gain one-stop access to full biocompatibility, interventional, and surgical research and pathology services within a world-class facility. ISO 17025 accredited, AAALAC accredited, USDA licensed, and GLP compliant, American Preclinical Services offers you the bundled resources you require to achieve rigorous medical device testing in a single laboratory operation.

Share on Google+ August 28, 2017

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American Preclinical Services Receives AAALAC’s Global 3Rs Award for North America.

Category : Coronary Artery Disease, Uncategorized

American Preclinical Services (APS) has been awarded AAALAC’s Global 3Rs Award for all of North America (there are two-three other winners for other continents). This AAALAC award recognizes our development of a new testing methodology, the In-vitro Blood Loop Assay, as a replacement for the Canine NonAnticoagulated Venous Implant (NAVI) Model for testing thrombogenicity of medical devices. This is truly a

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Share on Google+ August 7, 2017

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Pathology Matters, part 3 of a 3 part series: Semiquantitative Histopathology Scoring

Category : Uncategorized

Preclinical studies generating semiquantitative histopathology data are welcomed by regulatory agencies because, theoretically, reproducible and comparable results would be obtained with independent observers. But is that necessarily the case? Many factors influence the interpretation and reproducibility of semiquantitative data. Histopathology results are dependent on establishing appropriate scoring criteria. Semiquantitative scoring, with categorical ranking of observed changes, is also subject to

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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 27, 2017

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FDA changes that are now in effect.

Category : FDA, Regulatory

The Food and Drug Administration (FDA) is amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review boards (IRBs) for devices have changed. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act)

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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+ May 22, 2017

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Dystrophic Mineralization of Costal Cartilage in Hartley Guinea Pigs

Category : Histopathology, Publication, Toixcology

The University of Minnesota College of Veterinary Medicine and American Preclinical Services collaborate to document a previously undocumented novel lesion of Hartley guinea pigs, dystrophic mineralization of costal cartilage, as an incidental finding.  Abstract Hartley guinea pigs are widely used animal models of disease, particularly in studies of osteoarthritis. The purpose of this study was to investigate lesions in the

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