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Category Archives: In-vivo Testing

Share on Google+ October 28, 2016

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Combining Safety and Systemic Toxicology Studies: A Pathologist’s Viewpoint

Category : In-vivo Testing, Medical Device testing

Efforts to reduce the number of animals used in preclinical studies, both for humane reasons and a desire to reduce development costs, have prompted clients to consider concurrent investigational safety studies and systemic toxicology studies in their large animal models. Is this approach one that might work for you? Here is a pathologist’s viewpoint of some of the issues, both

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Share on Google+ October 18, 2016

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FDA Issues Notice of Proposed Rulemaking Regarding 21 CFR Part 58, Good Laboratory Practice (GLP).

Category : FDA, GLP, In-vivo Testing

The proposed changes would affect all participants in GLP trials:  Sponsors, Testing Facilities and supporting laboratory services.  We encourage all affected parties to review and comment on the proposed changes.  The public comment period for the proposed changes closes November 22, 2016.  Details on the proposed changes and how to comment are available on the Federal Register website:  https://www.federalregister.gov/documents/2016/08/24/2016-19875/good-laboratory-practice-for-nonclinical-laboratory-studies APS

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Share on Google+ October 16, 2015

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New Guidance! FDA New Guidance for Industry, General Considerations for Animal Studies for Medical Devices

Category : FDA, GLP, In-vivo Testing, Medical Device testing, Study Management, Uncategorized

On October 14, 2015, FDA released a draft guidance entitled, “General Considerations for Animal Studies for Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff“.  The purpose of this document is, once final, to supercede FDA’s current Guidance entitled General Considerations for Animal Studies for Cardiovascular Devices, which was issued on July 29, 2010. The Big Picture

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Share on Google+ June 29, 2015

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ISO/TC 194 – Biological and Clinical Evaluation of Medical Devices

Category : APS Service Offerings, In-vitro testing, In-vivo Testing, ISO, ISO/TC 194, Medical Device testing

APS Staff participated in the annual gathering of Technical Committee 194 of the International Standards Organization which is responsible for the continuing development and revisions of the guidelines for “Biological and Clinical Evaluation of Medical Devices”. The output of this committee and the associated 17 working groups is critical in the global processes standardizing biological test methods for the evaluation

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Share on Google+ June 3, 2015

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Computed Tomography (CT) Imaging in Preclinical Research

Category : APS Service Offerings, Cardiology, In-vivo Testing, Interventional Medicine, Medical Device testing

Computed Tomography (CT) scanners have been in use for over 40 years and when it comes to aiding in clinical diagnosis, has changed the face of medical imaging. CT scans provide a higher level of detailed images than with standard X-ray or fluoroscopy. This holds especially true in the case of organs, blood vessels and muscle beds. CT scanning, when

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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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