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Monthly Archives: October 2016

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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